Identity
- Trade Name
- ASI RPR Automated Control Set FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls. FDA UDI
- Model / Reference
- NC-905002.5A FDA UDI
- Description
- RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls. FDA UDI
Identifiers
- Catalog Number
- NC-905002.5A FDA UDI
- Primary DI / UDI-DI
- 00816057021697 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
No
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
ASI RPR Automated Control Set by Arlington Scientific, Inc. — 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
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 6c36002b-10a8-4990-b8f2-28e671c0b22d 35 fields · synced Jul 18, 2026