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BD Affirm™ VPIII Ambient Temperature Transport System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- BD Affirm™ VPIII Ambient Temperature Transport System FDA UDI
- Generic Name
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Kit Affirm Att System 100 Ea FDA UDI
- Model / Reference
- 446255 FDA UDI
- Description
- Kit Affirm Att System 100 Ea FDA UDI
Identifiers
- Catalog Number
- 446255 FDA UDI
- Primary DI / UDI-DI
- 30382904462551 FDA UDI
- 510(k) Number
- K920536 FDA UDI
- FDA Product Code
- LIO FDA UDI
- GMDN Term
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
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: Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BD Affirm™ VPIII Ambient Temperature Transport System by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- Aptima® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Xpert® — CEPHEID · Class II
- BD Affirm™ VPIII Sample Collection Sets — BECTON DICKINSON AND COMPANY · Class I
- BD Affirm™ VPIII Microbial Identification Test — BECTON DICKINSON AND COMPANY · Class I
- BD Vaginal Panel on BD COR System — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
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 8ef4e29f-fafd-406d-a7a8-61c701996245 37 fields · synced Jun 8, 2026