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
Ureaplasma urealyticum IgG ELISA	EIA-4623	FDA UDI	Class I	Unknown
Salivary Estradiol HS ELISA	SLV-6145	FDA UDI	Class I	Active
Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA	EIA-5188	FDA UDI	Class I	Active
TSH (ultrasensitive) ELISA	EIA-1790	FDA UDI	Class II	Active
Salivary 17-OH Progesterone ELISA	SLV-3140	FDA UDI	Class I	Unknown
LH-Urine ELISA	EIA-1290	FDA UDI	Class I	Active
Anti-Cardiolipin Screen ELISA	EIA-3589	FDA UDI	Class II	Unknown
Ascaris IgG ELISA	EIA-5854	FDA UDI	Class I	Active
Schistosoma IgG ELISA	EIA-3512	FDA UDI	Class I	Active
Poliomyelitis ELISA	EIA-2558	FDA UDI	Class I	Unknown
Pregnenolone Direct ELISA	EIA-4170	FDA UDI	N/A	Active
ACTH (Adrenocorticotropic Hormone) ELISA	EIA-3647	FDA UDI	Class II	Active
Anti-Sm ELISA	EIA-3577	FDA UDI	Class II	Active
Anti-SS-B ELISA	EIA-3576	FDA UDI	Class II	Active
Free Triiodothyronine (fT3) ELISA	EIA-4107	FDA UDI	Class II	Active
Giardia lamblia Antigen (stool) ELISA	EIA-3477	FDA UDI	Class II	Unknown
Sali-Tubes 100	SLV-4158	FDA UDI	Class I	Unknown
Legionella pneumophila IgG ELISA	EIA-5645	FDA UDI	Class II	Active
Free Testosterone ELISA	EIA-4638	FDA UDI	Class I	Active
Haemophilus influenza B IgG ELISA	EIA-2530	FDA UDI	Class II	Unknown
Dhea-S	CLA4652	FDA UDI	Class I	Active
T3 free	HYE-5356	FDA UDI	Class II	Active
Dopamine ELISA	EIA-4161	FDA UDI	Class I	Unknown
Dhea	HYE-5346	FDA UDI	Class I	Active
Estrone Serum	CLA-4654	FDA UDI	Class I	Active
Sm RNP IgG ELISA	EIA-2785	FDA UDI	Class II	Active
Mumps IgM ELISA	EIA-3847	FDA UDI	Class I	Active
TGF-Beta 2 ELISA	EIA-2396	FDA UDI	Class I	Unknown
Androstenedione ELISA	EIA-3265	FDA UDI	Class I	Active
Adenovirus Antigen (stool) ELISA	EIA-3444	FDA UDI	Class I	Unknown
Estradiol ELISA	EIA-2693	FDA UDI	Class I	Active
Cotinine ELISA	EIA-5917	FDA UDI	Class I	Active
Ureaplasma urealyticum IgG ELISA	EIA-4623	FDA UDI	Class I	Unknown
T3 Total ELISA	EIA-4569	FDA UDI	Class II	Active
Igf-1 600 Elisa	EIA-4140	FDA UDI	Class I	Active
Progesterone ELISA	EIA-1561	FDA UDI	Class I	Active
Insulin ELISA	EIA-2935	FDA UDI	Class I	Unknown
Proinsulin ELISA	EIA-1560	FDA UDI	Class I	Unknown
Measles Virus IgG Avidity ELISA	EIA-5967	FDA UDI	Class I	Unknown
Salivary Testosterone ELISA	SLV-3013	FDA UDI	Class I	Active
T-4 Total ELISA	EIA-4568	FDA UDI	Class II	Active
Anti-Thyroglobulin (Anti-Tg) ELISA	EIA-4110	FDA UDI	Class II	Active
Proteinase-3 IgG ELISA	EIA-2778	FDA UDI	Class II	Active
Salivary Progesterone HS ELISA	SLV-6145	FDA UDI	Class I	Unknown
Fsh Elisa	EIA-1288	FDA UDI	Class I	Active
Catcombi ELISA	EIA-3175	FDA UDI	Class I	Unknown
Free Testosterone ELISA	EIA-6101	FDA UDI	Class I	Active
Rheumatoid Factor Screen ELISA	EIA-3583	FDA UDI	Class II	Active
Cardiolipin IgM ELISA	EIA-2789	FDA UDI	Class II	Active
Insulin	HYE-5361	FDA UDI	Class I	Unknown

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