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BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit FDA UDI
- Generic Name
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Kit Flu A+B 30 Test Physician Veritor FDA UDI
- Model / Reference
- 256045 FDA UDI
- Description
- Kit Flu A+B 30 Test Physician Veritor FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3328 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
BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.
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- CorDx Tyfast — CORETESTS, INC. · N
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Cleared under the same submission
K112277 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI bc754aff-f0a1-4a02-9f56-8f54f1b5d1af 37 fields · synced Jun 1, 2026