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
Giardia/Cryptosporidium Ag (stool) ELISA	EIA-6059	FDA UDI	Class II	Unknown
Total Thyroxine (T4) ELISA	EIA-1781	FDA UDI	Class II	Active
Sperm Antibody ELISA	EIA-1826	FDA UDI	Class I	Active
Histamine ELISA	EIA-5827	FDA UDI	Class I	Active
Anti TPO Ab ELISA	EIA-3561	FDA UDI	Class II	Unknown
Estrone ELISA	EIA-4174	FDA UDI	Class I	Active
Mycoplasma pneumoniae IgG ELISA	EIA-3499	FDA UDI	Class I	Unknown
Prolactin ELISA	EIA-1291	FDA UDI	Class I	Unknown
Cornybacterium diphtheriae toxin IgG ELISA	EIA-3824	FDA UDI	Class I	Active
Epstein Barr Virus VCA IgG ELISA	EIA-2793	FDA UDI	Class I	Unknown
Estradiol (serum) ELISA	CLA-4664	FDA UDI	Class I	Active
Salivary Progesterone ELISA	SLV-2931	FDA UDI	Class I	Active
ANA Detect ELISA	EIA-4117	FDA UDI	Class II	Active
hGH ELISA	EIA-3552	FDA UDI	Class I	Unknown
TGF-Beta 1 ELISA	EIA-1864	FDA UDI	Class I	Unknown
pANCA (MPO) ELISA)	EIA-3597	FDA UDI	Class II	Active
LH-Serum ELISA	EIA-1289	FDA UDI	Class I	Active
Anti-dsDNA IgA ELISA	EIA-3565	FDA UDI	Class II	Unknown
Echinococcus IgG ELISA	EIA-3472	FDA UDI	Class I	Unknown
EBV-EA IgG ELISA	EIA-2796	FDA UDI	Class I	Unknown
α1-Microglobulin ELISA	EIA-5100	FDA UDI	Class I	Unknown
Vitamin C (Ascorbic Acid)	ENZ-4888	FDA UDI	Class I	Active
Trichinella spiralis IgG ELISA	EIA-3521	FDA UDI	Class I	Active
c-ANCA (PR3) ELISA	EIA-3596	FDA UDI	Class II	Unknown
Testosterone ELISA	EIA-1559	FDA UDI	Class I	Unknown
Bordetella pertussis IgG ELISA	EIA-3450	FDA UDI	Class I	Active

DRG Instruments Gesellschaft mit beschränkter Haftung

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