Identity
- Trade Name
- ASI RPR Dropper Needle Cover FDA UDI
- Generic Name
- Treponema pallidum reagin antibody IVD, kit, agglutination FDA UDI
- Device Name
- Blunt, 20 gauge needle cover FDA UDI
- Model / Reference
- NC-5072-002 FDA UDI
- Description
- Blunt, 20 gauge needle cover FDA UDI
Identifiers
- Catalog Number
- NC-5072-002 FDA UDI
- Primary DI / UDI-DI
- 00816057021239 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDI
Category: Treponema pallidum reagin antibody IVD, kit, agglutination
ASI RPR Dropper Needle Cover by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI a8b2bc8f-90bf-43fa-aaf1-b1acefb925e1 38 fields · synced Jul 18, 2026