Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent FDA UDI
- Device Name
- AccuDiag ™ SLE Latex Test Kit is a latex slide agglutination assay for the qualitative and semiquantitative detection of anti-deoxyribonucleoprotein (anti-DNP) in human serum FDA UDI
- Model / Reference
- DACD351-50 FDA UDI
- Description
- AccuDiag ™ SLE Latex Test Kit is a latex slide agglutination assay for the qualitative and semiquantitative detection of anti-deoxyribonucleoprotein (anti-DNP) in human serum FDA UDI
Identifiers
- Catalog Number
- 351-50 FDA UDI
- Primary DI / UDI-DI
- 00850049545907 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
Yes
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
AccuDiag ™ by Diagnostic Automation, 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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 56945e89-c002-4c09-9ea6-913f83ae9fa1 37 fields · synced Jun 8, 2026