Identity
- Trade Name
- ASI SLE Slide Test FDA UDI
- Generic Name
- Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent FDA UDI
- Device Name
- Detection of Anti-DNP, associated with Systemic Lupus Erythematosus FDA UDI
- Model / Reference
- NC-3501000 FDA UDI
- Description
- Detection of Anti-DNP, associated with Systemic Lupus Erythematosus FDA UDI
Identifiers
- Catalog Number
- NC-3501000 FDA UDI
- Primary DI / UDI-DI
- 00816057020256 FDA UDI
- 510(k) Number
- K821385 FDA UDI
- FDA Product Code
- DHC FDA UDI
- GMDN Term
- Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5820 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: Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
ASI SLE Slide Test by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent.
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- Detector Lex SLE — IMMUNOSTICS, INC. · Class II
- Detector Lex SLE — IMMUNOSTICS, INC. · Class II
- ASI SLE Slide Test — Arlington Scientific, Inc. · Class II
- ASI SLE Slide Test — Arlington Scientific, Inc. · Class II
- ASI SLE Slide Test — Arlington Scientific, Inc. · Class II
- ASI SLE Slide Test — Arlington Scientific, Inc. · Class II
- ASI SLE Slide Test — Arlington Scientific, Inc. · Class II
Cleared under the same submission
K821385 also covers:
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test — Arlington Scientific, Inc.
- ASI SLE Slide Test Control Set — 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 41a5b096-2dc5-4fa9-985c-9554c2efa223 38 fields · synced Jul 18, 2026