Identity
- Trade Name
- ANA Screen ELISA Test Kit FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs. FDA UDI
- Model / Reference
- 4884261 FDA UDI
- Description
- The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs. FDA UDI
Identifiers
- Catalog Number
- 4884261 FDA UDI
- Primary DI / UDI-DI
- 00840733101014 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
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
No
FDA UDI
Category: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
ANA Screen ELISA Test Kit by Meridian Bioscience, Inc. — 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
- ANA-8-Profile ELISA — DRG International, Inc. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- ANA Detect ELISA — DRG International, Inc. · Class II
- 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
- Autoimmune EIA — Bio-Rad Laboratories
- Immco — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 589e42db-f66e-429f-82f8-ec5137e07f23 37 fields · synced Jun 6, 2026