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
Sperm Antibody ELISA	EIA-4249	FDA UDI	Class I	Active
Dhea-S	HYE-5347	FDA UDI	Class I	Active
ANA Screen IgG ELISA	EIA-2773	FDA UDI	Class II	Unknown
Crosslaps Serum ELISA	EIA-2124	FDA UDI	Class I	Active
17 OH-Progesterone ELISA	EIA-1292	FDA UDI	Class I	Active
Candida albicans IgG ELISA	EIA-3458	FDA UDI	Class II	Active
TSH Receptor Autoantibody ELISA	EIA-3369	FDA UDI	Class II	Active
Sample Preparation System (Stool)	EIA-5674	FDA UDI	Class I	Active
Human Growth Hormone (HGH) ELISA	EIA-1787	FDA UDI	Class I	Active
Pregnenolone ELISA	EIA-4912	FDA UDI	Class I	Unknown
Rickettsia IgG ELISA	EIA-5297	FDA UDI	Class I	Active
Normetanephrine (Urine) ELISA	EIA-2749	FDA UDI	Class I	Unknown
LH-Serum ELISA	EIA-1289	FDA UDI	Class I	Unknown
Fsh	HYE-5355	FDA UDI	Class I	Active
Anti-SS-A (Ro) ELISA	EIA-3573	FDA UDI	Class II	Active
Metanephrine (Urine) ELISA	EIA-2748	FDA UDI	Class I	Unknown
Dhea	HYE-5346	FDA UDI	Class I	Unknown
Rheumatoid Factor IgA ELISA	EIA-3586	FDA UDI	Class II	Active
Progesterone (17-a-OH Progesterone)	HYE-5333	FDA UDI	Class I	Unknown
Anti-Scl-70 ELISA	EIA-3580	FDA UDI	Class II	Unknown
Free Triiodothyronine (fT3) ELISA	EIA-2385	FDA UDI	Class II	Active
Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA	EIA-1429	FDA UDI	Class I	Active
Myoglobin ELISA	EIA-3955	FDA UDI	Class II	Unknown
Free Estriol	HYE-5351	FDA UDI	Class I	Active
ANA-8-Screen ELISA	EIA-3562	FDA UDI	Class II	Active
Anti-Cardiolipin IgA ELISA	EIA-3588	FDA UDI	Class II	Active
Progesterone	HYE-5368	FDA UDI	Class I	Unknown
Immunoglobulin E (IgE) ELISA	EIA-1788	FDA UDI	Class II	Active
Prolactin	HYE-5369	FDA UDI	Class I	Active
Anti-Cardiolipin IgG/IgM ELISA	EIA-3587	FDA UDI	Class II	Active
Influenza Virus B IgG ELISA	EIA-3796	FDA UDI	Class I	Unknown
Insulin	HYE-5361	FDA UDI	Class I	Active
Anti TG Ab ELISA	EIA-3708	FDA UDI	Class II	Active
17 OH-Progesterone ELISA	EIA-1292	FDA UDI	Class I	Unknown
Bordetella pertussis IgG ELISA	EIA-3450	FDA UDI	Class I	Unknown
SSB (La) IgG ELISA	EIA-2783	FDA UDI	Class II	Active
Lysozyme (stool) ELISA	EIA-6100	FDA UDI	Class I	Unknown
Lysozyme (stool) ELISA	EIA-6100	FDA UDI	Class I	Unknown
Cardiolipin IgA ELISA	EIA-2790	FDA UDI	Class II	Active
Mycoplasma hominis IgG ELISA	EIA-4559	FDA UDI	Class I	Unknown
Dhea-S Elisa	EIA-1562	FDA UDI	Class I	Active
Cornybacterium diphtheriae toxin IgG ELISA	EIA-3824	FDA UDI	Class I	Unknown
Androstenedione ELISA	EIA-3265	FDA UDI	Class I	Unknown
Sperm Antibody ELISA	EIA-4249	FDA UDI	Class I	Unknown
Aspergillus fumigatus IgG ELISA	EIA-6129	FDA UDI	Class I	Unknown
C-Reactive Protein HS ELISA	EIA-3954	FDA UDI	Class II	Active
Fsh Elisa	EIA-4098	FDA UDI	Class I	Active
ANA Combi (ANA-8-Profile) ELISA	EIA-3563	FDA UDI	Class II	Active
Anti-dsDNA IgM ELISA	EIA-3564	FDA UDI	Class II	Unknown
Anti-Insulin ELISA	EIA-3608	FDA UDI	Class I	Unknown

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