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Salimetrics

SALIMETRICS, LLC · Model N/A · UDI-DI 00859410006153

PEJ
0
510(k) clearances
0
Adverse events
1
Recalls
0
Facilities

Description

High Sensitivity Salivary Estriol Enzyme Immunoassay Kit

Recalls

DateFirmReason
2016-07-14DRG Instruments GmbHLower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.

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Data 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.