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Sign in to claim this brandDRG Instruments Gesellschaft mit beschränkter Haftung
US
Last updated May 24, 2026
What DRG Instruments Gesellschaft mit beschränkter Haftung makes
DRG Instruments produces in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits for laboratory testing, including assays for thyroid markers such as estradiol, luteinizing hormone, and thyroid antibodies. Their portfolio also covers autoimmune markers like antinuclear antibodies (ANA), rheumatoid factor, and extractable nuclear antigens (ENA), as well as specific infectious disease antibodies such as Coxiella burnetii and Legionella pneumophila. Additional assays include salivary estradiol, adrenocorticotropic hormone (ACTH), and free triiodothyronine (fT3).
These diagnostic kits are classified under FDA’s In Vitro Diagnostic Device regulations, with most falling into Class I or Class II categories. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DRG Instruments Gesellschaft mit beschränkter Haftung manufacture?
DRG Instruments manufactures in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits designed for laboratory use. Their portfolio includes assays for thyroid markers like estradiol, luteinizing hormone, and thyroid antibodies, as well as autoimmune disease markers such as antinuclear antibodies (ANA), rheumatoid factor, and extractable nuclear antigens (ENA). They also produce tests for infectious disease antibodies, including those for Coxiella burnetii (Q-Fever) and Legionella pneumophila. These kits are intended for clinical testing in regulated laboratory settings.
Where is DRG Instruments Gesellschaft mit beschränkter Haftung based?
DRG Instruments Gesellschaft mit beschränkter Haftung is based in the United States. The company operates from this location while developing and distributing its IVD enzyme immunoassay kits globally.
Which regulatory registries list DRG Instruments’ devices?
DRG Instruments’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. regulatory requirements for in vitro diagnostic devices, helping healthcare providers and authorities verify the identification and classification of their products.
How are DRG Instruments’ devices classified under FDA regulations?
DRG Instruments’ IVD enzyme immunoassay kits are classified under the FDA’s In Vitro Diagnostic Device regulations, primarily as Class I or Class II devices. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the intended use, potential health impact, and the level of regulatory oversight required.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- drg-international.com
- —
- —
- [email protected]
- Phone
- 973-564-7555
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 317134468
Catalogue (276)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TGF-Beta 1 ELISA | EIA-1864 | FDA UDI | Class I | Unknown |
| Androstenedione ELISA | EIA-5050 | FDA UDI | Class I | Unknown |
| Anti-Jo-1 ELISA | EIA-3581 | FDA UDI | Class II | Active |
| Anti-Thyroid Peroxidase (Anti-TPO) ELISA | EIA-4114 | FDA UDI | Class II | Active |
| Borrelia burgdorferi IgG (Lyme) ELISA | EIA-2810 | FDA UDI | Class II | Active |
| Leptospira IgG ELISA | EIA-4245 | FDA UDI | Class II | Active |
| Mycoplasma hominis IgG ELISA | EIA-4559 | FDA UDI | Class I | Unknown |
| Prolactin | HYE-5369 | FDA UDI | Class I | Unknown |
| DNA (ds) IgG ELISA | EIA-2774 | FDA UDI | Class II | Unknown |
| Anti-Scl-70 ELISA | EIA-3580 | FDA UDI | Class II | Active |
| Adenovirus IgG ELISA | EIA-3446 | FDA UDI | Class I | Unknown |
| Free Estriol | HYE-5351 | FDA UDI | Class I | Unknown |
| Sali-Tubes 500 | SLV-4157 | FDA UDI | Class I | Unknown |
| Prolactin ELISA | EIA-1291 | FDA UDI | Class I | Active |
| Bordetella pertussis Toxin (PT) IgG ELISA | EIA-6133 | FDA UDI | Class I | Unknown |
| Igf-1 600 Elisa | EIA-4140 | FDA UDI | Class I | Unknown |
| Toxocara IgG ELISA | EIA-3518 | FDA UDI | Class II | Active |
| Estradiol (serum) ELISA | CLA-4664 | FDA UDI | Class I | Unknown |
| Bordetella pertussis Toxin (PT) IgG ELISA | EIA-6133 | FDA UDI | Class I | Unknown |
| Estradiol | HYE-5349 | FDA UDI | Class I | Active |
| T-3 | HYE-5697 | FDA UDI | Class II | Active |
| Entamoeba histolytica IgG ELISA | EIA-3830 | FDA UDI | Class II | Active |
| Diphtheria IgG ELISA | EIA-2514 | FDA UDI | Class I | Unknown |
| Trichinella spiralis IgG ELISA | EIA-3866 | FDA UDI | Class I | Active |
| Salivary Testosterone ELISA | SLV-3013 | FDA UDI | Class I | Unknown |
| Total Triiodothyronine (tT3) ELISA | EIA-5266 | FDA UDI | Class II | Active |
| Brucella IgG ELISA | EIA-3455 | FDA UDI | Class II | Active |
| Myeloperoxidase IgG ELISA | EIA-2776 | FDA UDI | Class II | Active |
| Anti-RNP/Sm ELISA | EIA-3578 | FDA UDI | Class II | Active |
| EPO (Erythropoietin) ELISA | EIA-3646 | FDA UDI | Class II | Active |
| GAD65 Ab ELISA | EIA-4087 | FDA UDI | Class II | Active |
| Scl-70 IgG ELISA | EIA-2786 | FDA UDI | Class II | Active |
| Dhea Elisa | EIA-3415 | FDA UDI | Class I | Unknown |
| ENA Screen ELISA | EIA-3571 | FDA UDI | Class II | Active |
| C-Peptide ELISA | EIA-1293 | FDA UDI | Class I | Active |
| Influenza Virus A IgG ELISA | EIA-3793 | FDA UDI | Class I | Active |
| Sperm Antibody ELISA | EIA-1826 | FDA UDI | Class I | Unknown |
| Mycoplasma pneumoniae IgG ELISA | EIA-3499 | FDA UDI | Class I | Active |
| Anti-Lactoferrin ELISA | EIA-3602 | FDA UDI | Class I | Unknown |
| Anti-dsDNA IgG ELISA | EIA-3438 | FDA UDI | Class II | Active |
| H. Pylori IgG ELISA | EIA-2815 | FDA UDI | Class I | Unknown |
| Measles Virus IgG ELISA | EIA-3844 | FDA UDI | Class I | Active |
| Influenza Virus A IgG ELISA | EIA-3793 | FDA UDI | Class I | Unknown |
| Dopamine ELISA | EIA-4615 | FDA UDI | Class I | Unknown |
| Progesterone (serum) ELISA | CLA-4663 | FDA UDI | Class I | Active |
| Anti-dsDNA Screen ELISA | EIA-3566 | FDA UDI | Class II | Active |
| 5-Hiaa Elisa | EIA-1886 | FDA UDI | Class I | Unknown |
| Gliadin IgG ELISA | EIA-3371 | FDA UDI | Class II | Unknown |
| Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA | EIA-5188 | FDA UDI | Class I | Unknown |
| Dhea-S Elisa | EIA-1562 | FDA UDI | Class I | Unknown |
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