Data / Medical devices / United States / DRG International, Inc.
DRG International, Inc.: FDA-registered device maker in Springfield, NJ, United States, 72 510(k) clearances
DRG International, Inc. is registered with the FDA (registration 2245285) in Springfield, NJ, United States. It lists 98 device types. The FDA files 72 510(k) clearances under its listings, the newest dated August 27, 2018. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2245285
- Address
- 841 Mountain Ave, Springfield, NJ, United States, 07081
- Owner or operator
- BIOCHECK, INC. (9033543)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- April 22, 1998
- Registered through
- 2026
- Brand names listed
- 21-Hydroxylase Autoantibody ELISA, 25 OH Vitamin D Total ELISA, ?1-Microglobulin ELISA, ACTH (Adrenocorticotropic Hormone) ELISA, AMTOX-DIP A-2 Jar, AMTOX-DIP A-3 Jar, AMTOX-DIP B-1 Jar, AMTOX-DIP B-2 Jar and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 21-Hydroxylase Antibody (21-Ohab) | PCG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | CDA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Antibodies, Gliadin | MST | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antibody Igm, If, Epstein-Barr Virus | LJN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, B. Pertussis | GOX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Cf, Aspergillus Spp. | JWT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Ebv, Capsid | MCD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | GMO | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigens, All, Leptospira Spp. | GRY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antisera, Cf, Influenza Virus A, B, C | GNW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antisera, Fluorescent, Adenovirus 1-33 | GNY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Cf, Q Fever | GPR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Antiserum, Fluorescent, C. Diphtheriae | GOS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, General Use, Thin Layer Chromatography | DPA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Assay, Erythropoietin | GGT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Candida Species, Antibody Detection | LSG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chromatography (Thin Layer), Clinical Use | KZS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cryptosporidium Spp. | MHJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dengue Virus Antigen Assay | QCU | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Elisa, Antibody, West Nile Virus | NOP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Elisa, Trichinella Spiralis | MDT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Epstein-Barr Virus, Other | LSE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Giardia Spp. | MHI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Ige, Antigen, Antiserum, Control | DGC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Immunochemical, Lysozyme (Muramidase) | JMR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Immunochemical, Thyroglobulin Autoantibody | JNL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Lactoferrin, Antigen, Antiserum, Control | DEG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Legionella, Spp., Elisa | MJH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | JMQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioassay, Triiodothyronine Uptake | KHQ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Acth | CKG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Androstenedione | CIZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Calcitonin | JKR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Corticosterone | CHA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Cortisol | CGR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Estriol | CGI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Estrone | CGF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Free Thyroxine | CEC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Human Growth Hormone | CFL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Immunoreactive Insulin | CFP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Parathyroid Hormone | CEW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Pregnenolone | JNG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Progesterone | JLS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Total Thyroxine | CDX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Radioimmunoassay, Total Triiodothyronine | CDP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Immunoassay, Igg | KTO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagent, Rickettsia Serological | LSQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Reagents, Cysticercosis | MDJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Respiratory Syncytial Virus - Elisa | MCE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sperm, Antigen, Antiserum, Control | DFQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Anticardiolipin Immunological | MID | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Beta-2-Microglobulin Immunological | JZG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Rheumatoid Factor | DHR | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Thyroid Autoantibody | JZO | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Test System, Nicotine, Cotinine, Metabolites | MRS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wright'S Stain | IAF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2018 | K181473 | DENV Detect NS1 ELISA | QCU | Substantially Equivalent | InBios International, Inc. | accessdata.fda.gov |
| July 20, 2018 | K181017 | Free Testosterone AccuBind ELISA Test System | CDZ | Substantially Equivalent | Monobind, Inc. | accessdata.fda.gov |
| July 15, 2013 | K123364 | 25OH VITAMIN D TOTAL ELISA TEST | MRG | Substantially Equivalent | Diasource Immunoassays, S.A. | accessdata.fda.gov |
| December 20, 2012 | K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | PCG | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| September 6, 2011 | K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... | JJX | Substantially Equivalent | Immunodiagnostic Systems , Ltd. | accessdata.fda.gov |
| October 27, 2010 | K100499 | ORGENTEC RHEUMATOID FACTOR EIA | DHR | Substantially Equivalent | Orgentec Diagnostika GmbH | accessdata.fda.gov |
| January 29, 2008 | K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | JLX | Substantially Equivalent | Drg Intl., Inc. | accessdata.fda.gov |
| January 27, 2006 | K052649 | DRG SLV TESTOSTERONE ELISA TEST | CDZ | Substantially Equivalent | Drg Intl., Inc. | accessdata.fda.gov |
| July 22, 2004 | K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | JLS | Substantially Equivalent | Ibl GmbH | accessdata.fda.gov |
| June 30, 2004 | K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | NOP | Substantially Equivalent | Focus Technologies, Inc. | accessdata.fda.gov |
| September 10, 2003 | K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | JZO | Substantially Equivalent | Kronus Market Development Associates, Inc. | accessdata.fda.gov |
| August 22, 2003 | K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | KLI | Substantially Equivalent | Monobind | accessdata.fda.gov |
| August 18, 2003 | K030730 | FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT | CDZ | Substantially Equivalent | Diagnostics Biochem Canada, Inc. | accessdata.fda.gov |
| May 2, 2003 | K030929 | ANA DETECT | LJM | Substantially Equivalent | Orgentec Diagnostika GmbH | accessdata.fda.gov |
| April 5, 2002 | K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | CEC | Substantially Equivalent | Monobind | accessdata.fda.gov |
| July 20, 2001 | K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | DCK | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| September 26, 2000 | K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | JZG | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 7, 2000 | K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | GGT | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| April 17, 2000 | K000043 | DRG AURICA ELISA TESTOSTERONE KIT | CDZ | Substantially Equivalent | Drg Intl., Inc. | accessdata.fda.gov |
| September 21, 1999 | K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | DGC | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| August 12, 1999 | K991820 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI | LYR | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 25, 1999 | K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | DDC | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 22, 1999 | K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | JLW | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 22, 1999 | K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | JLW | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 2, 1999 | K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | KLI | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| June 2, 1999 | K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | CDP | Substantially Equivalent | Biocheck, Inc. | accessdata.fda.gov |
| March 26, 1999 | K990207 | GLIADIN IGA ELISA TEST SYSTEM | MST | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| March 26, 1999 | K990204 | GLIADIN IGG ELISA TEST SYSTEM | MST | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| September 3, 1998 | K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | JKR | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| August 21, 1998 | K981120 | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | LSE | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| August 19, 1998 | K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | CKG | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| June 2, 1998 | K981021 | ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM | MID | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 2, 1998 | K981014 | ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM | MID | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| May 18, 1998 | K981020 | ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM | MID | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| February 17, 1998 | K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | MOB | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| February 17, 1998 | K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | MOB | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| December 23, 1997 | K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | CEW | Substantially Equivalent | Sangui Biotech, Inc. | accessdata.fda.gov |
| September 2, 1997 | K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | CGJ | Substantially Equivalent | Monobind | accessdata.fda.gov |
| July 3, 1997 | K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | DDC | Substantially Equivalent | Monobind | accessdata.fda.gov |
| July 3, 1997 | K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | JNL | Substantially Equivalent | Monobind | accessdata.fda.gov |
| June 24, 1997 | K971780 | THYROTROPIN(TSH) ELISA | JLW | Substantially Equivalent | Monobind | accessdata.fda.gov |
| June 16, 1997 | K971779 | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | CDP | Substantially Equivalent | Monobind | accessdata.fda.gov |
| June 16, 1997 | K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | KLI | Substantially Equivalent | Monobind | accessdata.fda.gov |
| April 10, 1997 | K964448 | PROTEINASE-3 IGG ELISA TEST SYSTEM | MOB | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| April 10, 1997 | K964446 | MYELOPEROXIDASE ELISA TEST SYSTEM | MOB | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| April 8, 1997 | K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | JIR | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 18, 1996 | K962062 | ORGENTEC ANTI-SM ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 18, 1996 | K962057 | ORGENTEC ANTI-RNP/SM ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 15, 1996 | K962055 | ORGENTEC ANTI-SCL 70 ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 15, 1996 | K962054 | ORGENTEC ANTI-SS-A(RO) ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 15, 1996 | K962053 | ORGENTEC ANTI-JO-1 ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| November 15, 1996 | K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA | LJM | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| October 10, 1996 | K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY | MID | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| September 9, 1996 | K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY | MID | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| July 24, 1996 | K961012 | VZV IGG ELISA TEST SYSTEM | LFY | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| May 23, 1996 | K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY | MID | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| May 8, 1996 | K961277 | RF IGM ELISA TEST SYSTEM | DHR | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| March 20, 1996 | K955134 | ORGENTEC ENASCREEN ELISA ASSAY | LLL | Substantially Equivalent | Orgentec | accessdata.fda.gov |
| November 9, 1995 | K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | LRM | Substantially Equivalent | Orgentec | accessdata.fda.gov |
| September 25, 1995 | K944449 | EBV-VCA IGM ELISA TEST STSTEM | LSE | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 20, 1995 | K952130 | ORGENTEC ANTI-TG ELISA | JZO | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| June 20, 1995 | K952129 | ORGENTEC ANTI-TPO ELISA | JZO | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| July 28, 1994 | K940362 | ANA SCREEN ELISA TEST SYSTEM | LLL | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 10, 1994 | K941409 | ENA PROFILE-6 ELISA TEST SYSTEM | LJM | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| June 10, 1994 | K941014 | ENA SCREEN ELISA TEST SYSTEM | LJM | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| December 15, 1993 | K933267 | AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM | LJM | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| April 2, 1993 | K924096 | CMV ELISA TEST SYSTEM | LFZ | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| January 11, 1993 | K924091 | EBV-VCA IGG ELISA TEST SYSTEM | MCD | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| May 2, 1990 | K900196 | LYME IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| December 13, 1989 | K895292 | LYME IGG ELISA TEST SYSTEM | LSR | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| March 2, 1989 | K885317 | LYME ELISA TEST SYSTEM | LSR | Substantially Equivalent | Zeus Scientific, Inc. | accessdata.fda.gov |
| March 22, 1978 | K780361 | T3 UPTAKE TEST | KHQ | Substantially Equivalent | Monobind | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 2, 2026 | 99799 | Class II | Ongoing | Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test) | Potential for false negative patient results. | accessdata.fda.gov |
| June 4, 2025 | 97196 | Class III | Ongoing | Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31). | accessdata.fda.gov |
| October 7, 2024 | 95785 | Class II | Ongoing | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results. | accessdata.fda.gov |
| September 13, 2024 | 95429 | Class III | Ongoing | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292 | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk. | accessdata.fda.gov |
| July 5, 2024 | 95021 | Class III | Ongoing | Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva. | Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients. | accessdata.fda.gov |
| December 21, 2021 | 89680 | Class II | Terminated | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293 | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible | accessdata.fda.gov |
| October 18, 2021 | 88949 | Class II | Ongoing | Total Thyroxine (T4) ELISA; REF EIA-1781 | Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples. | accessdata.fda.gov |
| November 9, 2009 | 53841 | Not yet classified | Terminated | CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this | CHROMagar Products are labeled incorrectly. Label currently states that the product is for IVD use, when it should state that the product is intended For Research Use, Not for use in diagnostic procedures. | accessdata.fda.gov |
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Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.