Identity
- Trade Name
- NovaLisa Influenza Virus B IgG FDA UDI
- Generic Name
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin). FDA UDI
- Model / Reference
- INFG0300 FDA UDI
- Description
- The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin). FDA UDI
Identifiers
- Catalog Number
- INFG0300 FDA UDI
- Primary DI / UDI-DI
- ENTIINFG03000 FDA UDI
- FDA Product Code
- GNW FDA UDI
- GMDN Term
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3330 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: Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
NovaLisa Influenza Virus B IgG by Gold Standard Diagnostics Frankfurt GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Influenza Virus B IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Influenza Virus B IgG ELISA — DRG International, Inc. · Class I
- Anti-Influenza B Virus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Influenza B IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Frankfurt GmbH
Sources (1)
- FDA UDI 972ba165-1d16-4a1a-b794-58c7b5aec71e 36 fields · synced May 29, 2026