Data / Medical devices / United States / Monobind, Inc.
Monobind, Inc.: FDA-registered device maker in Lake Forest, CA, United States, 12 510(k) clearances
Monobind, Inc. is registered with the FDA (registration 2020726) in Lake Forest, CA, United States. It lists 65 device types. The FDA files 12 510(k) clearances under its listings, the newest dated July 20, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2020726
- Address
- 100 N. Pointe DR., Lake Forest, CA, United States, 92630
- Owner or operator
- MONOBIND, INC. (2020726)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- October 26, 1992
- Registered through
- 2026
- Brand names listed
- 0 Calibrator FSH-Ferritin-Folate & Vitamin B12 Matrix (Ref 731MM), 0 Calibrator Multiligand Matrix (Ref 440MM), 0 Calibrator Steroid & Thyroid (T3-T4) Matrix (Ref 625MM), 17-OHP AccuBind® ELISA Test System (Ref 5225-300A, 5225-300B), 17-OHP AccuLite® CLIA Test System (Ref 5275-300A, 5275-300B), 17-OHP-SI AccuBind® ELISA Test System (Ref 9925-300A, 9925-300B), 17-OHP-SI AccuLite® CLIA Test System (Ref 9975-300A, 9975-300B), 903 DBS Collection Cards - 5 Samples (Ref 621MM) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Acid, Folic, Radioimmunoassay | CGN | 2 | Manufacturer for export | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Anti-Müllerian Hormone Test System | PQO | 2 | Manufacturer for export | accessdata.fda.gov |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | 2 | Manufacturer for export | accessdata.fda.gov |
| Antigen, Inflammatory Response Marker, Sepsis | NTM | 2 | Manufacturer for export | accessdata.fda.gov |
| Biosensor, Immunoassay, Myoglobin | MVE | 2 | Manufacturer for export | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Specification developer | accessdata.fda.gov |
| Colorimetric Method, Cpk Or Isoenzymes | JHY | 2 | Manufacturer for export | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Manufacturer for export | accessdata.fda.gov |
| Enzyme Immunoassay, Digoxin | KXT | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | 2 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | 2 | Manufacturer for export | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | 2 | Manufacturer for export | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | 2 | Manufacturer for export | accessdata.fda.gov |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | 2 | Manufacturer for export | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | 2 | Manufacturer for export | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Manufacturer for export | accessdata.fda.gov |
| Immunoassay Method, Troponin Subunit | MMI | 2 | Manufacturer for export | accessdata.fda.gov |
| Immunochemical, Thyroglobulin Autoantibody | JNL | 2 | Manufacturer | accessdata.fda.gov |
| Interleukin 6 | QLC | N | Manufacturer for export | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Newborn Screening Specimen Collection Paper | PJC | 2 | Manufacturer for export | accessdata.fda.gov |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioassay, Triiodothyronine Uptake | KHQ | 2 | Manufacturer | accessdata.fda.gov |
| Radioassay, Vitamin B12 | CDD | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Acth | CKG | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Aldosterone | CJM | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Androstenedione | CIZ | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Calcitonin | JKR | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Cortisol | CGR | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estradiol | CHP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estriol | CGI | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estrone | CGF | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Free Thyroxine | CEC | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Human Growth Hormone | CFL | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Immunoglobulins (G, A, M) | CFQ | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Immunoreactive Insulin | CFP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Parathyroid Hormone | CEW | 2 | Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Progesterone | JLS | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Total Triiodothyronine | CDP | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Coronavirus Serological | QKO | N | Manufacturer for export | accessdata.fda.gov |
| System, Test, C-Reactive Protein | DCN | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Carcinoembryonic Antigen | DHX | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Human Chorionic Gonadotropin | DHA | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Immunological, Antigen, Tumor | MOI | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Rheumatoid Factor | DHR | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Thyroglobulin | MSW | 2 | Manufacturer for export | accessdata.fda.gov |
| System, Test, Vitamin D | MRG | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | NSF | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | 2 | Manufacturer for export | accessdata.fda.gov |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | 3 | Manufacturer for export | accessdata.fda.gov |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | 2 | Manufacturer | accessdata.fda.gov |
| Transferrin, Antigen, Antiserum, Control | DDG | 2 | Manufacturer for export | 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 |
|---|
| July 20, 2018 | K181017 | Free Testosterone AccuBind ELISA Test System | CDZ | Substantially Equivalent | Monobind, Inc. | accessdata.fda.gov |
| April 4, 2008 | K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | JLW | Substantially Equivalent | Monobind, Inc. | accessdata.fda.gov |
| August 22, 2003 | K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | KLI | Substantially Equivalent | Monobind | accessdata.fda.gov |
| April 5, 2002 | K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | CEC | Substantially Equivalent | Monobind | accessdata.fda.gov |
| February 4, 1998 | K980088 | T-UPTAKE MICROPLATE EIA | KHQ | Substantially Equivalent | Monobind | 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 | K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | CFT | 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 |
Compare with other makers
Updated July 20, 2018. 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.