Identity
- Trade Name
- VDRL Antigen Kit FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema Pallidum bacteria (syphilis). Kit contains 5.5 ml VDRL Antigen reagent, 60 ml of buffered diluent and product instructions. FDA UDI
- Model / Reference
- V-55 FDA UDI
- Description
- VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema Pallidum bacteria (syphilis). Kit contains 5.5 ml VDRL Antigen reagent, 60 ml of buffered diluent and product instructions. FDA UDI
Identifiers
- Catalog Number
- V-55 FDA UDI
- Primary DI / UDI-DI
- B224V551 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
VDRL Antigen Kit by Cenogenics Corp. — 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
- Cenogenics Corp.
Sources (1)
- FDA UDI feed8fb9-b765-4da9-ac62-de04185df9a0 36 fields · synced Jun 1, 2026