FDA Registration
Active
🇩🇪 Germany
DRG INSTRUMENTS GMBH
Reg #: 3002800697
·
FEI: 3002800697
·
Expires 2026
Products
95
Proprietary Names
173
Establishment Types
3
Classifications
95
Registration Details
- Registration Name
- DRG INSTRUMENTS GMBH
- Registration Number
- 3002800697
- FEI Number
- 3002800697
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FRAUENBERGSTRASSE 18
- City
- MARBURG Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K962052
Owner / Operator
- Firm Name
- BIOCHECK, INC.
- Operator Number
- 9033543
- Address
- 3451 Vincent Road, --
- City
- Pleasant Hill
- State
- CA
- Postal Code
- 94523
- Country
- US
- Correspondent
- Johanna - Saito
US Agent
- Business Name
- DRG International, Inc.
- Contact Name
- Ina Hairston
- Address
- 841 Mountain Ave
- City
- Springfield
- State
- NJ
- ZIP
- 07081
- Country
- US
- [email protected]
- Phone
- 973 5647555 ext. 229
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2022-12-15 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2022-12-16 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2022-12-15 |
| Antigen, Cf, Aspergillus Spp. | JWT | Class 1 | Microbiology | No | 2022-12-15 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2022-12-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-11-06 |
| St2 Assay | OYG | Class 2 | Clinical Chemistry | No | 2013-11-06 |
| Antiserum, Fluorescent, C. Diphtheriae | GOS | Class 1 | Microbiology | No | 2022-12-14 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2022-12-15 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| Ige, Antigen, Antiserum, Control | DGC | Class 2 | Immunology | No | 2007-12-05 |
| Radioimmunoassay, Calcitonin | JKR | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2022-12-19 |
| Antisera, Fluorescent, Adenovirus 1-33 | GNY | Class 1 | Microbiology | No | 2022-12-16 |
| Elisa, Trichinella Spiralis | MDT | Class 1 | Microbiology | No | 2022-12-15 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2022-12-16 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2022-12-16 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Apparatus, General Use, Thin Layer Chromatography | DPA | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2022-12-15 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2022-12-15 |
| Test System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2022-12-16 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| System, Test, Beta-2-Microglobulin Immunological | JZG | Class 2 | Immunology | No | 2007-12-05 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2022-12-16 |
| Antigens, All, Leptospira Spp. | GRY | Class 2 | Microbiology | No | 2022-12-14 |
| Cryptosporidium Spp. | MHJ | Class 2 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2001-04-25 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Reagent, Rickettsia Serological | LSQ | Class 1 | Microbiology | No | 2022-12-16 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2022-12-16 |
| Elisa, Antibody, West Nile Virus | NOP | Class 2 | Microbiology | No | 2022-12-15 |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 2022-12-16 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2022-12-16 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2022-12-16 |
| Assay, Erythropoietin | GGT | Class 2 | Hematology | No | 2022-12-16 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Dengue Virus Antigen Assay | QCU | Class 2 | Microbiology | No | 2023-03-22 |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | Class 2 | Microbiology | No | 2022-12-15 |
| Antigen, Ebv, Capsid | MCD | Class 1 | Microbiology | No | 2022-12-16 |
| Antigen, Fluorescent Antibody Test, Schistosoma Mansoni | GNH | Class 1 | Microbiology | No | 2022-12-14 |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | Class 1 | Microbiology | No | 2022-12-15 |
| Radioimmunoassay, Total Thyroxine | CDX | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Respiratory Syncytial Virus - Elisa | MCE | Class 1 | Microbiology | No | 2022-12-15 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2026-05-11 |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | Class 2 | Immunology | No | 2022-12-15 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2022-12-14 |
| Candida Species, Antibody Detection | LSG | Class 2 | Microbiology | No | 2022-12-15 |
| Alpha-1 Microglobulin, Antigen, Antiserum, Control | MGA | Class 1 | Immunology | No | 2022-12-15 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2022-12-15 |
| M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | JMQ | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2007-12-05 |
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2022-12-14 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2022-12-16 |
| Retinol-Binding Protein, Antigen, Antiserum, Control | CZS | Class 1 | Immunology | No | 2022-12-14 |
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Chromatography (Thin Layer), Clinical Use | KZS | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| Lactoferrin, Antigen, Antiserum, Control | DEG | Class 1 | Immunology | No | 2022-12-14 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2022-12-15 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 1998-04-22 |
| Antigen, B. Pertussis | GOX | Class 1 | Microbiology | No | 2022-12-14 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2026-06-15 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2022-12-13 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Antigens, Cf (Including Cf Control), Adenovirus 1-33 | GOD | Class 1 | Microbiology | No | 2022-12-14 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2022-12-15 |
| Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. | GMO | Class 2 | Microbiology | No | 2022-12-16 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Legionella, Spp., Elisa | MJH | Class 2 | Microbiology | No | 2022-12-15 |
| Antisera, Cf, Influenza Virus A, B, C | GNW | Class 1 | Microbiology | No | 2022-12-14 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2026-06-02 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2026-05-18 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2022-12-16 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2022-12-13 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2022-12-15 |
| Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | CDA | Class 1 | Clinical Chemistry | No | 2023-05-03 |
| 21-Hydroxylase Antibody (21-Ohab) | PCG | Class 2 | Immunology | No | 2022-12-15 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2026-05-18 |
| Reagents, Cysticercosis | MDJ | Class 1 | Microbiology | No | 2022-12-16 |
| Antiserum, Cf, Q Fever | GPR | Class 1 | Microbiology | No | 2022-12-14 |
| Antigen, Agglutinating, Echinococcus Spp. | GPF | Class 1 | Microbiology | No | 2022-12-14 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2022-12-12 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Radioimmunoassay, Corticosterone | CHA | Class 1 | Clinical Chemistry | No | 2022-12-14 |
| Immunochemical, Lysozyme (Muramidase) | JMR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2022-12-15 |
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
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
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
Epstein Barr Virus VCA IgM ELISA
ENA Screen (entractable nuclear antigen) ELISA
C-Peptide ELISA, Insulin (human) Ultrasensitive ELISA
Anti-Cardiolipin IgG/IgM ELISA
Total Thyroxine (T4) ELISA
TSH (ultrasensitive) ELISA
Adenovirus IgG ELISA
Sample Preparation System (Stool)
EIA-3865 Toxocara canis IgG ELISA
Entamoeba histolytica Ag (stool) ELISA, Toxocara IgG ELISA
Vitamin C (Ascorbic Acid)
Legionella pneumophila IgG ELISA
Anti-dsDNA IgG ELISA, Anti-dsDNA IgM ELISA, Anti-dsDNA IgA ELISA, Anti-dsDNA Screen ELISA
Influenza Virus A IgG ELISA, Influenza Virus B IgG ELISA
Triiodothyronine (T3) ELISA
Myeloperoxidase IgG ELISA
FSH ELISA
Cardiolipin IgM ELISA
HSV-1 IgM ELISA
EIA-1887 Cortisol
Multi Ligand Control
SALI-TUBES 500, SALI-TUBES 100
T3 Total ELISA
Total Thyroxine (tT4) ELISA
Thyroid Stimulating Hormone (TSH) ELISA
c-ANCA (PR3) ELISA
Salivary Testosterone ELISA
ENA Screen ELISA, ENA-6-Profile ELISA
Insulin ELISA, Anti-Insulin ELISA, Insulin
Anti-Sm ELISA
Mumps Virus IgG ELISA
Serotonin ELISA
21-Hydroxylase Autoantibody ELISA
EIA-5653 Anti-CCP.ELISA
Progesterone (serum), Progesterone ELISA, Progesterone, Salivary Progesterone ELISA, Salivary Progesterone HS ELISA
Anti-Jo-1 ELISA
Taenia Solium IgG ELISA
Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA, Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA
Echinococcus IgG ELISA
LuMate 4400 PC controlled Microplate Luminometer, DRG:HYBRiD.XL®
Androstenedione ELISA, Androstenedione (40 tests)
Corticosterone ELISA
RF IgM (Rheumatoid Factor) ELISA
Lysozyme (Food) ELISA
Micro-albumin ELISA
EBV-EBNA IgM ELISA
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)