Identity
- Trade Name
- BD Macro-Vue™ Card Test Rotator FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- BD Macro-Vue™ Card Test Rotator FDA UDI
- Model / Reference
- 278051 FDA UDI
- Description
- BD Macro-Vue™ Card Test Rotator FDA UDI
Identifiers
- Catalog Number
- 278051 FDA UDI
- Primary DI / UDI-DI
- 00382902780519 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Depth — 8 Inch FDA UDIWidth — 7 Inch FDA UDIHeight — 5.25 Inch FDA UDI
Category: Treponema pallidum reagin antibody IVD, kit, agglutination
BD Macro-Vue™ Card Test Rotator by Becton Dickinson And Company — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 15ce7747-e9a7-4654-a1f0-e2f5021d8a6a 37 fields · synced Jun 8, 2026