Devices

Device Recall Autoimmune EIA ANA Screening Kit

Model / Serial
Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- New York, US.
Product Description
Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, || Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. || Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of Device Recall Autoimmune EIA ANA Screening Kit

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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