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Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System FDA UDI
- Generic Name
- Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
- Model / Reference
- IB-2112 FDA UDI
Identifiers
- Catalog Number
- IB-2112 FDA UDI
- Primary DI / UDI-DI
- B110IB21120 FDA UDI
- FDA Product Code
- GNS FDA UDI
- GMDN Term
- Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent 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, reagent
Influenza B Virus Antigen Substrate, 12 wells, For IFA Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI e57b1513-df79-47b2-9d47-e61002faf42f 35 fields · synced Jun 1, 2026