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
DRG:HYBRiD.XL®	HYB-5252	FDA UDI	Class I	Unknown
Progesterone (17-a-OH Progesterone)	HYE-5333	FDA UDI	Class I	Active
Progesterone ELISA	EIA-1561	FDA UDI	Class I	Unknown
CMV IgG ELISA	EIA-2797	FDA UDI	Class II	Active
Lysozyme (Food) ELISA	EIA-6027	FDA UDI	Class I	Unknown
RF IgM (Rheumatoid Factor) ELISA	EIA-2775	FDA UDI	Class II	Unknown
Borrelia burgdorferi IgM (Lyme) ELISA	EIA-2811	FDA UDI	Class II	Active
Lh Elisa	EIA-4103	FDA UDI	Class I	Active
Micro-Albumin ELISA	EIA-3881	FDA UDI	Class I	Unknown
Testosterone ELISA	EIA-1559	FDA UDI	Class I	Active
Entamoeba histolytica IgG ELISA	EIA-3474	FDA UDI	Class II	Active
Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA	EIA-5189	FDA UDI	Class I	Active
Estradiol Sensitive ELISA	EIA-4399	FDA UDI	Class I	Active
Adrenaline ELISA	EIA-1908	FDA UDI	Class I	Unknown
Triiodothyronine (T3) ELISA	EIA-1780	FDA UDI	Class II	Active
Estradiol Sensitive ELISA	EIA-4399	FDA UDI	Class I	Unknown
Jo-1 IgG ELISA	EIA-2787	FDA UDI	Class II	Active
Rheumatoid Factor IgM ELISA	EIA-3585	FDA UDI	Class II	Active
Thyroid Stimulating Hormone (TSH) ELISA	EIA-1782	FDA UDI	Class II	Active
Free Thyroxine (fT4) ELISA	EIA-4266	FDA UDI	Class II	Active
Progesterone, 17-a-OH ELISA	CLA-4665	FDA UDI	Class I	Unknown
Salivary Progesterone HS ELISA	SLV-5911	FDA UDI	Class I	Active
Salivary Estradiol ELISA	SLV-4188	FDA UDI	Class I	Active
Lysozyme (Food) ELISA	EIA-6027	FDA UDI	Class I	Unknown
Lh	HYE-5362	FDA UDI	Class I	Active
Estrone ELISA	EIA-4079	FDA UDI	Class I	Active
Androstenedione	HYE-5339	FDA UDI	Class I	Unknown
Estradiol ELISA	EIA-2693	FDA UDI	Class I	Unknown
RSV IgG ELISA	EIA-3507	FDA UDI	Class I	Unknown
Calcitonin ELISA	EIA-3648	FDA UDI	Class II	Active
Insulin ELISA	EIA-2935	FDA UDI	Class I	Active
Gliadin IgA ELISA	EIA-3370	FDA UDI	Class II	Active
Strongyloides IgG ELISA	EIA-4208	FDA UDI	Class I	Active
Dhea Elisa	EIA-3415	FDA UDI	Class I	Active
PTH (Parathyroid) Intact ELISA	EIA-3645	FDA UDI	Class II	Active
ENA-6-Profile ELISA	EIA-3901	FDA UDI	Class II	Active
Varicella Zoster Virus (VZV) IgG ELISA	EIA-2808	FDA UDI	Class II	Active
ANCA Screen IgG ELISA	EIA-2777	FDA UDI	Class II	Active
T3-Uptake ELISA	EIA-3267	FDA UDI	Class II	Active
Measles Virus IgG Avidity ELISA	EIA-5967	FDA UDI	Class I	Unknown
Thyrotropin (TSH) ELISA	EIA-4111	FDA UDI	Class II	Active
Adenovirus IgG ELISA	EIA-3446	FDA UDI	Class I	Active
Total Triiodothyronine (tT3) ELISA	EIA-5275	FDA UDI	Class II	Active
ENA-6-Profile ELISA	EIA-2780	FDA UDI	Class II	Unknown
Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA	EIA-5189	FDA UDI	Class I	Unknown
Beta-2 Microglobulin ELISA	EIA-1789	FDA UDI	Class II	Active
Fsh	HYE-5355	FDA UDI	Class I	Unknown
LH-Urine ELISA	EIA-1290	FDA UDI	Class I	Unknown
TPO IgG ELISA	EIA-2791	FDA UDI	Class II	Active
B. burgdorferi IgG/IgM ELISA	EIA-2809	FDA UDI	Class II	Active

DRG Instruments Gesellschaft mit beschränkter Haftung

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