Identity
- Trade Name
- Status Flu A+B card FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Status Flu A+B EUDAMEDStatus Flu A & B; 4 Test Sample Kit FDA UDIStatus Flu A+B; 25 Test Kit FDA UDI
- Model / Reference
- 36025 EUDAMEDBSP-510-04-00 FDA UDIBSP-510-25-02 FDA UDI
- Description
- Status Flu A & B; 4 Test Sample Kit FDA UDIStatus Flu A+B; 25 Test Kit FDA UDI
Identifiers
- Catalog Number
- BSP-510-04-00 FDA UDIBSP-510-25-02 FDA UDI
- Primary DI / UDI-DI
- 10743816001508 EUDAMEDFDA UDI10743816001218 FDA UDI
- Basic UDI-DI
- B-10743816001508 EUDAMED
- FDA Product Code
- GNX FDA UDI
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS EUDAMED
- GMDN Term
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Status Flu A+B card by Princeton Biomeditech Corp. — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (3)
- FDA UDI e07cd152-b994-400d-bd58-6dbbd30f990c 35 fields · synced Jun 20, 2026
- FDA UDI 74825130-6b20-42ba-9cf9-44972ef81b3a 36 fields · synced May 30, 2026
- EUDAMED 5ab58b49-f330-45d1-bab8-5c2f6cbafd9e 61 fields · synced Jun 20, 2026