Identity
- Trade Name
- QuickVue FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- QkVue Flu Bulk 25T FDA UDI
- Model / Reference
- 00317 FDA UDI
- Description
- QkVue Flu Bulk 25T FDA UDI
Identifiers
- Catalog Number
- 00317 FDA UDI
- Primary DI / UDI-DI
- 30014613003175 FDA UDI
- FDA Product Code
- GNX FDA UDI
- GMDN Term
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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 A/B virus antigen IVD, kit, rapid ICT, clinical
Explore the QkVue Flu Bulk 25T, a rapid immunochromatographic test for influenza A/B virus antigen detection in clinical specimens. Learn about its features, indications, and usage guidelines.
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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
- Quidel Corp.
Sources (1)
- FDA UDI edf83549-b7b5-43c5-9c7c-6edc2427a7a7 35 fields · synced Jun 29, 2026