ANA ACA Control ACA-1043
ANA ACA Control ACA-1043 is a Class II device made by Bion Enterprises, Ltd., listed in FDA GUDID since 12 Sep 2016 (UDI-DI B110ACA10430), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB110ACA10430 | Date12 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ANA ACA Control
- Generic name
- Multiple antinuclear antibody (ANA) IVD, control
- Model / Ref / Catalog
- ACA-1043
- Primary DI / UDI-DI
- B110ACA10430
- FDA product code
- DHN
- GMDN term
- Multiple antinuclear antibody (ANA) IVD, control
- Device class
- Class II
- Regulation number
- 866.5100
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control).
- ANTI-DNP MICROASSAY by Diamedix Corp.
- ANTI-NUCLEAR ANTIBODY TEST by Meloy Laboratories, Inc.
- ANA IFA: HEp-20-10 FA 1522-2010 by EUROIMMUN Medizinische Labordiagnostika AG
- ANA IFA: HEp-20-10 FA 1522-1010 by EUROIMMUN Medizinische Labordiagnostika AG
- ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- RHIGENE HEP-ANA TEST SYSTEM by Corgenix, Inc.
- ANTINUCLEAR ANTOBODY CELL SUBSTRATE by Immulok, Inc.
- ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT by Keith E. Abbott
- LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 by Bio-Rad
- ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT by Immuno-Products Industries