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K-ASSAY® Apo B Reagent (L)
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-024 · UDI-DI 00816426020177
DER
Prescription
1
510(k) clearances
3
Adverse events
2
Recalls
11
Facilities
Description
For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
| 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.