Data / Medical devices / Germany / DRG Instruments GMBH
DRG Instruments GMBH: FDA-registered device maker in MARBURG Hesse, Germany, 72 510(k) clearances
DRG Instruments GMBH is registered with the FDA (registration 3002800697) in MARBURG Hesse, Germany. It lists 99 device types. The FDA files 72 510(k) clearances under its listings, the newest dated August 27, 2018. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002800697
- Address
- Frauenbergstrasse 18, MARBURG Hesse, Germany, D-35039
- Owner or operator
- BIOCHECK, INC. (9033543)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- 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
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 |
|---|---|---|---|---|---|---|
| June 6, 2019 | 83177 | Class II | Terminated | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result. | accessdata.fda.gov |
| May 21, 2019 | 83183 | Class II | Terminated | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testost | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower | accessdata.fda.gov |
| July 14, 2016 | 80575 | Class II | Terminated | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva. | Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1. | accessdata.fda.gov |
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Updated August 27, 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.