Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, control FDA UDI
- Device Name
- SP Brand RPR Card Test FDA UDI
- Model / Reference
- B1077-12 FDA UDI
- Description
- SP Brand RPR Card Test FDA UDI
Identifiers
- Catalog Number
- B1077-12 FDA UDI
- Primary DI / UDI-DI
- 20885380114370 FDA UDI
- 510(k) Number
- K851504 FDA UDI
- FDA Product Code
- GMP FDA UDI
- GMDN Term
- Treponema pallidum reagin antibody IVD, control 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Treponema pallidum reagin antibody IVD, control
Cardinal Health by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K851504 also covers:
- ASI DIsposible Test Card — Arlington Scientific, Inc.
- ASI Disposible Stirrer Pipet — Arlington Scientific, Inc.
- ASI RPR Carbon Antigen — Arlington Scientific, Inc.
- ASI RPR Carbon Antigen — Arlington Scientific, Inc.
- ASI RPR Carbon Antigen — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
- ASI RPR Card Test for Syphilis — Arlington Scientific, Inc.
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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI ed3f23a6-1eed-405d-a67e-5661ec73b414 36 fields · synced Jun 8, 2026