Identity
- Trade Name
- BD Veritor™ Plus CLIA-Waived Combo Pack FDA UDI
- Generic Name
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Combo Veritor Plus CLIA- Waived Flu Kit FDA UDI
- Model / Reference
- 256074 FDA UDI
- Description
- Combo Veritor Plus CLIA- Waived Flu Kit FDA UDI
Identifiers
- Catalog Number
- 256074 FDA UDI
- Primary DI / UDI-DI
- 00382902560746 FDA UDI
- 510(k) Number
- K112277 FDA UDI
- FDA Product Code
- GTY FDA UDIGNX FDA UDI
- GMDN Term
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 FDA UDI866.3330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
BD Veritor™ Plus CLIA-Waived Combo Pack by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical.
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- WELLlife™ — WONDFO USA CO., LTD. · Class II
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- WELLlife™ — WONDFO USA CO., LTD. · Class II
- OSOM Flu SARS-CoV-2 Combo Test — Sekisui Diagnostics, LLC
- QuickFinder™ COVID-19/Flu Antigen ProTest — OSANG HEALTHCARE Co., Ltd. · Class II
- BinaxNOW COVID-19/Flu A&B — Alere Scarborough, Inc. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 80257f5b-4a5a-49bc-98b6-caa13b8b30f1 37 fields · synced Jun 8, 2026