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Mycoplasma hominis IgG ELISA

DRG International Inc · Model EIA-4559 · UDI-DI 00840239045591

CDX Prescription
10
510(k) clearances
100
Adverse events
1
Recalls
13
Facilities

Description

The DRG Mycoplasma hominis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma hominis in serum and plasma.

Recalls

DateFirmReason
2025-06-04DRG International, Inc.An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the

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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.