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K-ASSAY® Prealbumin Calibrator
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-054C · UDI-DI 00816426020405
JZJ
Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
33
Facilities
Description
For the calibration of the K-ASSAY® Prealbumin assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-11-10 | Abbott Laboratories Diagnostic Div | These specific protein assays are not meeting the 57-day on board stability claim |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.