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PREALBUMIN (PreALB)
RANDOX LABORATORIES LIMITED · Model PA3843 · UDI-DI 05055273204759
JZJ
Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
33
Facilities
Description
A prealbumin (transthyretin) test system is a device intended for the quantitative in vitro determination of prealbumin (transthyretin) concentration in serum.
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.