Identity
- Trade Name
- ASI RF Direct Slide Test FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- Detection fo Rheumatoid Factor, Export FDA UDI
- Model / Reference
- NC-700100DC-E FDA UDI
- Description
- Detection fo Rheumatoid Factor, Export FDA UDI
Identifiers
- Catalog Number
- NC-700100DC-E FDA UDI
- Primary DI / UDI-DI
- 00816057020492 FDA UDI
- 510(k) Number
- K821319 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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
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: Rheumatoid factor IVD, kit, agglutination
ASI RF Direct Slide Test by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K821319 also covers:
- ASI RF Direct Slide Test — Arlington Scientific, Inc.
- ASI RF Direct Slide Test — Arlington Scientific, Inc.
- ASI RF Direct Slide Test — Arlington Scientific, Inc.
- ASI RF Direct Slide Test Control Set — Arlington Scientific, Inc.
- ASI RF Direct Slide Tests for Export — Arlington Scientific, Inc.
- CARDINAL HEALTH — Cardinal Health 200, LLC
- CARDINAL HEALTH — Cardinal Health 200, LLC
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 fa1b4f43-fee1-47de-8915-3482f5c191a4 38 fields · synced Jul 18, 2026