Identity
- Trade Name
- ASI RPR Control Set FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Detection of Syphilis FDA UDI
- Model / Reference
- NC-905002.5 FDA UDI
- Description
- Detection of Syphilis FDA UDI
Identifiers
- Catalog Number
- NC-905002.5 FDA UDI
- Primary DI / UDI-DI
- 00816057020928 FDA UDI
- 510(k) Number
- K851504 FDA UDI
- FDA Product Code
- GMP 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Category: Treponema pallidum reagin antibody IVD, kit, agglutination
ASI RPR Control Set by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Treponema pallidum reagin antibody IVD, kit, agglutination.
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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
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 1344c739-7bf5-48ff-8679-fa7d194c2e1d 38 fields · synced Jul 18, 2026