Identity
- Trade Name
- Autoimmune EIA FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Autoimmune EIA ANA Screening Test FDA UDI
- Model / Reference
- 96AN FDA UDI
- Description
- Autoimmune EIA ANA Screening Test FDA UDI
Identifiers
- Catalog Number
- 96AN FDA UDI
- Primary DI / UDI-DI
- 00847817022319 FDA UDI
- 510(k) Number
- K954723 FDA UDI
- FDA Product Code
- LKJ 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
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: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA).
- HEp-2000® Colorzyme® ANA-Ro Test System — IMMUNO CONCEPTS INC
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- AESKULISA® ENA-6Pro — Aesku.Diagnostics GmbH & Co. KG · Class II
- HEp-2000® Colorzyme® ANA-Ro Test System — IMMUNO CONCEPTS INC
- Fluorescent ANA Test System — IMMUNO CONCEPTS INC
- ANA-8-Screen ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K954723 also covers:
- 96AN — Bio-Rad Laboratories
- 96AN — Bio-Rad Laboratories
- ANA PLATE — Bio-Rad Laboratories
- ANA PLATE — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Autoimmune EIA — Bio-Rad Laboratories
- Immco — CLARK LABORATORIES, INC.
- Immco Diagnostics — CLARK LABORATORIES, 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 21dee922-585f-43e1-a369-bff11ae5191f 38 fields · synced Jun 8, 2026