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NovaLisa Respiratory Syncytial Virus IgG

FDA UDI

Class I (US FDA UDI)

by Gold Standard Diagnostics Frankfurt GmbH

Identity

Trade Name
NovaLisa Respiratory Syncytial Virus IgG FDA UDI
Generic Name
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin). FDA UDI
Model / Reference
RSVG0380 FDA UDI
Description
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin). FDA UDI

Identifiers

Catalog Number
RSVG0380 FDA UDI
Primary DI / UDI-DI
ENTIRSVG03800 FDA UDI
FDA Product Code
MCE FDA UDI
GMDN Term
Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3480 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

NovaLisa Respiratory Syncytial Virus IgG by Gold Standard Diagnostics Frankfurt GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gold Standard Diagnostics Frankfurt GmbH

Sources (1)

  • FDA UDI 280ff5d4-3a86-434f-b395-d4a2ed5e9dae 36 fields · synced May 30, 2026