Question 1

What types of medical devices does DRG Instruments Gesellschaft mit beschränkter Haftung manufacture?

Accepted Answer

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.

Question 2

Where is DRG Instruments Gesellschaft mit beschränkter Haftung based?

Accepted Answer

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.

Question 3

Which regulatory registries list DRG Instruments’ devices?

Accepted Answer

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.

Question 4

How are DRG Instruments’ devices classified under FDA regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Entamoeba histolytica Ag (stool) ELISA	EIA-3473	FDA UDI	Class II	Unknown
Echinococcus IgG ELISA	EIA-3472	FDA UDI	Class I	Active
Thyrotropin (TSH) ELISA	EIA-5283	FDA UDI	Class II	Active
Salivary 17-OH Progesterone ELISA	SLV-3140	FDA UDI	Class I	Active
Free Estriol ELISA	EIA-1612	FDA UDI	Class I	Unknown
Salivary Estradiol ELISA	SLV-4188	FDA UDI	Class I	Unknown
Lh	HYE-5362	FDA UDI	Class I	Unknown
Dengue Virus NS1 Ag ELISA	EIA-6090	FDA UDI	Class I	Active
Progesterone (serum) ELISA	CLA-4663	FDA UDI	Class I	Unknown
Serotonin ELISA	EIA-1300	FDA UDI	Class I	Unknown
TGF-Beta 2 ELISA	EIA-2396	FDA UDI	Class I	Active
Anti-Lactoferrin ELISA	EIA-3602	FDA UDI	Class I	Unknown
Mumps Virus IgG ELISA	EIA-3846	FDA UDI	Class I	Active
Free Triiodothyronine (fT3) ELISA	EIA-5277	FDA UDI	Class II	Active
Total Thyroxine (tT4) ELISA	EIA-5279	FDA UDI	Class II	Active
Androstenedione	HYE-5339	FDA UDI	Class I	Active
Sample Preparation System (Stool)	EIA-5674	FDA UDI	Class I	Active
Aspergillus fumigatus IgG ELISA	EIA-2501	FDA UDI	Class I	Unknown
RSV IgG ELISA	EIA-3507	FDA UDI	Class I	Active
Corticosterone ELISA	EIA-4164	FDA UDI	Class I	Active
Taenia Solium IgG ELISA	EIA-3513	FDA UDI	Class I	Active
Fsh Elisa	EIA-1288	FDA UDI	Class I	Unknown
C-Peptide ELISA	EIA-1293	FDA UDI	Class I	Unknown
Retinol binding Protein (RBP)/RBP4 ELISA	EIA-4391	FDA UDI	Class I	Active
Epstein Barr Virus VCA IgM ELISA	EIA-2794	FDA UDI	Class I	Unknown
Progesterone	HYE-5368	FDA UDI	Class I	Active
Sm IgG ELISA	EIA-2784	FDA UDI	Class II	Active
Aspergillus fumigatus IgG ELISA	EIA-6129	FDA UDI	Class I	Active
DRG:HYBRiD.XL®	HYB-5252	EUDAMEDFDA UDI	Class I	Active
Anti-Insulin ELISA	EIA-3608	FDA UDI	Class I	Active
Influenza Virus B IgG ELISA	EIA-3796	FDA UDI	Class I	Active
Schistosoma mansoni IgG ELISA	EIA-3872	FDA UDI	Class I	Active
Salivary Progesterone ELISA	SLV-2931	FDA UDI	Class I	Unknown
Estrone ELISA	EIA-4174	FDA UDI	Class I	Unknown
21-Hydroxylase Autoantibody ELISA	EIA-5955	FDA UDI	Class II	Active
25 OH Vitamin D Total (90') ELISA	EIA-6087	FDA UDI	Class II	Active
ENA Screen (entractable nuclear antigen) ELISA	EIA-2779	FDA UDI	Class II	Active
Estradiol	HYE-5349	FDA UDI	Class I	Unknown
SSA (Ro) ELISA	EIA-2782	FDA UDI	Class II	Active
Cryptosporidium Antigen (stool) ELISA	EIA-3467	FDA UDI	Class II	Unknown
Leptopspira IgG ELISA	EIA-5751	FDA UDI	Class II	Active
Free Estriol ELISA	EIA-1612	FDA UDI	Class I	Active
Rheumatoid Factor IgG ELISA	EIA-3584	FDA UDI	Class II	Active
Dhea-S	HYE-5347	FDA UDI	Class I	Unknown
Cardiolipin IgG ELISA	EIA-2788	FDA UDI	Class II	Active
Free T3 ELISA	EIA-3801	FDA UDI	Class II	Active
Salivary Progesterone HS ELISA	SLV-5911	FDA UDI	Class I	Unknown
Corticosterone ELISA	EIA-4164	FDA UDI	Class I	Unknown
Micro-albumin ELISA	EIA-3881	FDA UDI	Class I	Unknown
Free Thyroxine (fT4) ELISA	EIA-4109	FDA UDI	Class II	Active

DRG Instruments Gesellschaft mit beschränkter Haftung

What DRG Instruments Gesellschaft mit beschränkter Haftung makes

Frequently asked questions

Information

Catalogue (276)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities