DRG INSTRUMENTS GMBH

FDA Device Registration & Listing · MARBURG Hesse, DE · Registration 3002800697

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002800697
FEI Number
3002800697
Entity Name
DRG INSTRUMENTS GMBH
City/State/Country
MARBURG Hesse, DE
Establishment Address
FRAUENBERGSTRASSE 18, MARBURG Hesse D-35039, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
BIOCHECK, INC. (Owner Number: 9033543)
Owner / Operator Contact Address
3451 Vincent Road, --, Pleasant Hill, CA 94523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K971779
PMA Number
N/A

All Registered Proprietary Names

Anti-SS-B ELISA Anti-Thyroid Peroxidase (Anti-TPO) ELISA Anti TG Ab ELISA Anti-SS-A (Ro) ELISA Aspergillus fumigatus IgG ELISA Histamine ELISA Presage ST2 Assay Kit, Presage ST2 Assay Kit Controls Cornybacterium diphtheriae toxin IgG ELISA p-ANCA (MPO) ELISA Free Testosterone ELISA Immunoglobulin E (IgE) ELISA Calcitonin ELISA T3-Uptake ELISA Adenovirus Antigen (stool) ELISA Trichinella spiralis IgG ELISA, Trichinella spiralis IgG ELISA, Strongyloides IgG ELISA,, Ascaris IgG ELISA H. Pylori IgG ELISA LH-Serum ELISA, LH-Urine ELISA, LH ELISA, LH Free Estriol ELISA, Free Estriol EBV-EA IgG ELISA Giardia lamblia Antigen (stool) ELISA , Giardia/Cryptosporidium Ag (stool) ELISA Thyrotropin (TSH) ELISA, T3-Uptake ELISA, Thyrotropin (TSH) ELISA Human Growth Hormone (HGH) ELISA, TGF-?1 ELISA, TGF-?2 ELISA, HGH (Human Growth Hormone) ELISA, IGF-1 600 ELISA De-Tox Tubes A-100, De-Tox Tubes B-100 Anti-Cardiolipin IgA ELISA 25 OH Vitamin D Total ELISA Cotinine ELISA Estrone Serum, Estrone ELISA, Estrone ELISA Crosslaps Serum ELISA Beta-2 Microglobulin ELISA ANA Screen IgG ELISA Leptospira IgG ELISA, Leptospira IgG ELISA Cardiolipin IgA ELISA Cryptosporidium Antigen (stool) ELISA Estradiol (serum), Estradiol ELISA, Estradiol, Salivary Estradiol ELISA, Salivary Estradiol HS ELISA Estradiol Sensitive ELISA PTH (Parathyroid) Intact ELISA Rickettsia IgG ELISA DHEA-S, DHEA-S ELISA, DHEA ELISA, DHEA, DHEA-S ANCA Screen IgG ELISA, Proteinase-3 IgG ELISA Free Thyroxine (fT4) ELISA West Nile Virus IgM (Flavivirus) ELISA Varicella Zoster Virus (VZV) IgG ELISA Borrelia burgdorferi IgG (Lyme) ELISA Gliadin IgG ELISA EPO (Erythropoietin) ELISA Prolactin ELISA, Prolactin Cardiolipin IgG ELISA Anti TPO Ab ELISA ENA-6-Profile ELISA, SSA (Ro) ELISA , Sm IgG ELISA, Sm RNP IgG ELISA, Sci-70 IgG ELISA, Jo-1 IgG ELISA Dengue Virus NS1 Ag ELISA Anti-Cardiolipin Screen ELISA Entamoeba histolytica IgG ELISA, Entamoeba histolytica IgG ELISA Epstein Barr Virus VCA IgG ELISA Schistosoma IgG ELISA, Schistosoma mansoni IgG ELISA Mycoplasma pneumoniae IgG ELISA T-4 Total ELISA Borrelia burgdorferi IgM (Lyme) ELISA RSV IgG ELISA Salivary 17-OH Progesterone ELISA Testosterone ELISA TSH Receptor Autoantibody ELISA Anti-RNP/Sm ELISA PSA Total Anti-Thyroglobulin (Anti-Tg) ELISA TPO IgG ELISA Rheumatoid Factor Screen ELISA, RF IgG (Rheumatoid Factor) ELISA, Rheumatoid Factor IgM ELISA, Rheumatoid Factor IgA ELISA Gliadin IgA ELISA Candida albicans IgG ELISA B. burgdorferi IgG/IgM ELISA ?1-Microglobulin ELISA ANA-8-Profile ELISA ANA-8-Screen ELISA ANA-8-Screen ELISA, ANA-8-Profile ELISA, ANA Detect ELISA ANA Detect ELISA Progesterone, 17-a-OH, 17 OH-Progesterone ELISA, Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA Progesterone (17-a-OH Progesterone) Lysozyme (stool) ELISA C-Reactive Protein HS ELISA Sperm Antibody ELISA, Sperm Antibody ELISA CMV IgG ELISA Retinol binding Protein (RBP)/RBP4 ELISA Pregnenolone Direct ELISA Anti-Scl-70 ELISA Free Thyroxine (fT4) ELISA AMTOX-DIP A-3 Jar Amtox Grams Blank B-100 Amtox Control THc Small Stand-off Jar THC-2 Amtox Discs Blank A-100 Toxi-Dip A-1 Small Stand-Off Jar Amtox DIP B-1 Reagent Concentrate Amtox Dip B-1-2-3 Reagent Concentrate THC Developing Solution Bottle AMTOX-DIP B-2 Jar Multiple devopment rack with Chromatography Jar and Cap Amtox Tubes B-100 Amtox Discs A Amtox Grams Blank A-100 AMTOX-Dip THC-1 Reagent Jar Microdispenser Amtox Alum. Disp. Concentration Cups Chromatography Jar with Cap Amtox Dip A-2 Reagent Concentrate AMTOX-DIP B-1 Jar Amtox DIP B-3 Reagent Concentrate Amtox DIP B-2 Reagent Concentrate OMEGA-12+ Extraction Concentrator Amtox DISCS A-1, Amtox Discs A-2, Amtox Discs A-3, Amtox DISCS A-4, Amtox Discs B-1 . Amtox Discs B-3 , Amtox Discs B-4 Amtox DIP A-3 Reagent Concentrate Amtox Control 19 HCl Standoff THC-3 Jar Amtox Discs Blank B-100 Small Stand-off Jar AMTOX-DIP A-1 AMTOX-DIP H2O Jar Amtox Discs B-2 Amtox Tubes A-100 AMTOX-DIP A-2 Jar Anti-Lactoferrin ELISA ACTH (Adrenocorticotropic Hormone) ELISA SHBG ELISA Measles Virus IgG ELISA, Measles Virus IgG Avidity ELISA FSH ELISA, FSH Bordetella pertussis IgG ELISA, Bordetella pertussis Toxin (PT) IgG ELISA Free Testosterone ELISA EIA-3517 Treponema Pallidum (Syphillis) IgG EIA-4267 Treponema pallidum (Syphillis) IgM DNA (ds) IgG ELISA Free Triiodothyronine (fT3) ELISA, Total Triiodothyronine (tT3) ELISA, Free Triiodothyronine (fT3) ELISA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-15
JNL Immunochemical, Thyroglobulin Autoantibody Immunology Class 2 866.5870 2022-12-16
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2022-12-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-15
JWT Antigen, Cf, Aspergillus Spp. Microbiology Class 1 866.3040 2022-12-15
IAF Wright'S Stain Hematology Class 1 864.1850 2022-12-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-11-06
OYG St2 Assay Clinical Chemistry Class 2 862.1117 2013-11-06
GOS Antiserum, Fluorescent, C. Diphtheriae Microbiology Class 1 866.3140 2022-12-14
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2022-12-15
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2022-12-13
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-12-05
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2022-12-15
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2022-12-19
GNY Antisera, Fluorescent, Adenovirus 1-33 Microbiology Class 1 866.3020 2022-12-16
MDT Elisa, Trichinella Spiralis Microbiology Class 1 866.3850 2022-12-15
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2022-12-16
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 1998-04-22
CGI Radioimmunoassay, Estriol Clinical Chemistry Class 1 862.1265 2022-12-14
LSE Epstein-Barr Virus, Other Microbiology Class 1 866.3235 2022-12-16
MHI Giardia Spp. Microbiology Class 2 866.3220 2022-12-16
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2022-12-16
CFL Radioimmunoassay, Human Growth Hormone Clinical Chemistry Class 1 862.1370 1998-04-22
DPA Apparatus, General Use, Thin Layer Chromatography Clinical Chemistry Class 1 862.2270 2022-12-16
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2022-12-15
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2022-12-15
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2022-12-16
CGF Radioimmunoassay, Estrone Clinical Chemistry Class 1 862.1280 2022-12-13
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-12-15
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2007-12-05
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2022-12-16
GRY Antigens, All, Leptospira Spp. Microbiology Class 2 866.3350 2022-12-14
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2022-12-16
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2022-12-16
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2001-04-25
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2022-12-13
LSQ Reagent, Rickettsia Serological Microbiology Class 1 866.3500 2022-12-16
JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Clinical Chemistry Class 1 862.1245 2022-12-14
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2022-12-16
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2022-12-16
NOP Elisa, Antibody, West Nile Virus Microbiology Class 2 866.3940 2022-12-15
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Microbiology Class 2 866.3900 2022-12-16
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2022-12-16
MST Antibodies, Gliadin Immunology Class 2 866.5750 2022-12-16
GGT Assay, Erythropoietin Hematology Class 2 864.7250 2022-12-16
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 1998-04-22
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2022-12-16
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2022-12-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-16
QCU Dengue Virus Antigen Assay Microbiology Class 2 866.3945 2023-03-22
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2022-12-15
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Microbiology Class 2 866.3220 2022-12-15
MCD Antigen, Ebv, Capsid Microbiology Class 1 866.3235 2022-12-16
GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni Microbiology Class 1 866.3600 2022-12-14
LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. Microbiology Class 1 866.3375 2022-12-15
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2022-12-13
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2022-12-16
MCE Respiratory Syncytial Virus - Elisa Microbiology Class 1 866.3480 2022-12-15
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2022-12-15
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2022-12-12
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2022-12-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-15
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2026-05-11
DDC Thyroglobulin, Antigen, Antiserum, Control Immunology Class 2 866.5870 2022-12-15
DDC Thyroglobulin, Antigen, Antiserum, Control Immunology Class 2 866.5870 2022-12-15
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2022-12-14
MST Antibodies, Gliadin Immunology Class 2 866.5750 2022-12-16
LSG Candida Species, Antibody Detection Microbiology Class 2 866.3165 2022-12-15
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2022-12-16
MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control Immunology Class 1 866.5400 2022-12-15
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control Immunology Class 2 866.5100 2022-12-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-15
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2022-12-15
JMQ M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) Clinical Chemistry Class 1 862.1490 2022-12-15
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2007-12-05
DFQ Sperm, Antigen, Antiserum, Control Immunology Class 1 866.5800 2022-12-14
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2022-12-16
CZS Retinol-Binding Protein, Antigen, Antiserum, Control Immunology Class 1 866.5765 2022-12-14
JNG Radioimmunoassay, Pregnenolone Clinical Chemistry Class 1 862.1615 2022-12-14
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-15
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2022-12-13
KZS Chromatography (Thin Layer), Clinical Use Clinical Chemistry Class 1 862.2270 2022-12-16
DEG Lactoferrin, Antigen, Antiserum, Control Immunology Class 1 866.5570 2022-12-14
CKG Radioimmunoassay, Acth Clinical Chemistry Class 2 862.1025 2022-12-13
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2026-05-11
LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg Microbiology Class 1 866.3520 2022-12-15
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 1998-04-22
GOX Antigen, B. Pertussis Microbiology Class 1 866.3065 2022-12-14
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2022-12-13
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2026-06-15
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2022-12-16
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2022-12-13

Official Correspondent

Johanna Saito

US Agent Details

Ina Hairston Business: DRG International, Inc. Email: qa@drg-international.com Phone: (973) 5647555

Related Public Records

Same Entity

BIOCHECK, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2953756 BIOCHECK, INC. Pleasant Hill, CA, US
2245285 DRG International, Inc. Springfield, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951364 Immunoprobe, Inc. MICROSOMAL EIA TEST KIT 1995-11-20
K000362 Zeus Scientific, Inc. MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM 2000-02-18
K250250 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Anti-Thyroid Peroxidase II 2025-10-17
K152061 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material 2016-03-03
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0022-2025 Qualigen Inc 2
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020 Roche Diagnostics Operations, Inc. 2
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017 Siemens Healthcare Diagnostics, Inc. 2
ADVIA Centaur XPT Immunoassay System
Z-0034-2008 Louisville Apl Diagnostics Inc 2
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002800697. Last updated year: 2026. Please use registration number 3002800697 when referencing this establishment in official correspondence.
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