Identity
- Trade Name
- ANA-8-Profile ELISA FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3563 FDA UDI
- Description
- ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3563 FDA UDI
- Primary DI / UDI-DI
- 00840239035639 FDA UDI
- 510(k) Number
- K030929 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening 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
Yes
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: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
ANA-8-Profile ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030929 also covers:
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
- DRG International, Inc.
Sources (1)
- FDA UDI 0853bbdb-fbfb-4d53-a358-d279fd7ab515 37 fields · synced May 30, 2026