Question 1

What types of medical devices does Gold Standard Diagnostics Frankfurt GmbH manufacture?

Accepted Answer

Gold Standard Diagnostics Frankfurt GmbH specializes in in vitro diagnostic (IVD) enzyme immunoassay (EIA) kits. These kits detect immunoglobulin G (IgG) antibodies against specific pathogens, such as bacteria, viruses, and parasites. Examples include tests for Coxiella burnetii (Q-Fever), Influenza A/B viruses, measles, Entamoeba histolytica, and parasitic infections like Strongyloides and Toxocara canis. The kits are designed for laboratory use to help diagnose infections caused by these agents.

Question 2

Where is Gold Standard Diagnostics Frankfurt GmbH based?

Accepted Answer

The company is based in the United States. While the name includes 'Frankfurt,' this appears to be part of the company’s branding rather than its physical location. The manufacturer operates from within the U.S., where it develops and produces its IVD enzyme immunoassay kits.

Question 3

Which regulatory registries list the devices manufactured by Gold Standard Diagnostics Frankfurt GmbH?

Accepted Answer

The devices produced by Gold Standard Diagnostics Frankfurt GmbH are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are the devices manufactured by Gold Standard Diagnostics Frankfurt GmbH classified under regulatory frameworks?

Accepted Answer

The company’s devices fall into two primary regulatory classifications: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a moderate risk and may require specific controls to ensure safety and performance. The classification depends on factors like the device’s intended use and potential health impact, as determined by regulatory authorities.

Question 5

What is the primary purpose of the enzyme immunoassay (EIA) kits produced by Gold Standard Diagnostics Frankfurt GmbH?

Accepted Answer

The EIA kits are designed for serological diagnosis in laboratory settings. They detect IgG antibodies in a patient’s blood, indicating prior exposure or infection by specific pathogens. For example, a kit for Coxiella burnetii IgG helps confirm Q-Fever infection, while a kit for Strongyloides detects parasitic infections. These tests aid clinicians in diagnosing infections and guiding treatment decisions.

Device	Model / Reference	Registries	Class	Status
NovaLisa Mumps Virus IgG	MUMG0340	FDA UDI	Class I	Active
NovaLisa Schistosoma mansoni IgG	SCHG0410	FDA UDI	Class I	Active
NovaLisa Adenovirus IgG	ADVG0010	FDA UDI	Class I	Active
NovaLisa Strongyloides	STRO0690	FDA UDI	Class I	Active
NovaLisa Toxocara canis IgG	TOCG0450	FDA UDI	Class I	Active
NovaLisa Respiratory Syncytial Virus IgG	RSVG0380	FDA UDI	Class I	Active
NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG	COX2G060	FDA UDI	Class I	Active
NovaLisa Trichinella spiralis IgG	TRIG0480	FDA UDI	Class I	Active
NovaLisa Taenia solium IgG	TAEG0420	FDA UDI	Class I	Active
NovaLisa Measles Virus IgG	MEAG0330	FDA UDI	Class I	Active
NovaLisa Brucella IgG	BRUG0050	FDA UDI	Class II	Active
NovaLisa Entamoeba histolytica IgG	ENTG0140	FDA UDI	Class II	Active
NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgG	COX1G060	FDA UDI	Class I	Active
NovaLisa Parainfluenza Virus 1, 2, 3 IgG	PAIG0360	FDA UDI	Class I	Active
NovaLisa Influenza Virus B IgG	INFG0300	FDA UDI	Class I	Active
NovaLisa Mycoplasma pneumoniae IgG	MYCG0350	FDA UDI	Class I	Active
NovaLisa Leptospira IgG	LEPG0660	FDA UDI	Class II	Active
NovaLisa Influenza Virus A IgG	INFG0290	FDA UDI	Class I	Active
NovaLisa Echinococcus IgG	ECHG0130	FDA UDI	Class I	Active

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