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Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]

BIOMERICA, INC. · Model 7024 · UDI-DI 08305900070248

JKR
1
510(k) clearances
38
Adverse events
1
Recalls
11
Facilities

Description

The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.

Recalls

DateFirmReason
2014-09-18BiomericaA potential issue with false high values.

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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.