Identity
- Trade Name
- BD Macro-Vue™ RPR™ Card Test, Kit No. 115 FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Kit No. 115: (150 qualitative tests), contains: one 3 mL amp. antigen, 20 G needle, dispensing bottle, 15 cards with ten 18 mm Circle spots ea. and 150-0.05 mL BD Dispenstirs™ devices. FDA UDI
- Model / Reference
- 275539 FDA UDI
- Description
- Kit No. 115: (150 qualitative tests), contains: one 3 mL amp. antigen, 20 G needle, dispensing bottle, 15 cards with ten 18 mm Circle spots ea. and 150-0.05 mL BD Dispenstirs™ devices. FDA UDI
Identifiers
- Catalog Number
- 275539 FDA UDI
- Primary DI / UDI-DI
- 00382902755395 FDA UDI
- FDA Product Code
- GMQ FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3820 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treponema pallidum reagin antibody IVD, kit, agglutination
BD Macro-Vue™ RPR™ Card Test, Kit No. 115 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI e6abbd70-1e79-4fb5-a9d0-d2b5ded9ad63 36 fields · synced Jun 1, 2026