Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA Anti-Sm/RNP Test FDA UDI
- Model / Reference
- 96SR FDA UDI
- Description
- Autoimmune EIA Anti-Sm/RNP Test FDA UDI
Identifiers
- Catalog Number
- 96SR FDA UDI
- Primary DI / UDI-DI
- 00847817022456 FDA UDI
- 510(k) Number
- K940588 FDA UDI
- FDA Product Code
- LKO FDA UDI
- GMDN Term
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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
Yes
FDA UDI
Category: Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 8bb8290f-daf3-4447-8fad-3d23e3c3f968 38 fields · synced Jun 8, 2026