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Histoplasma Antigen for Fungal Immunodiffusion

MERIDIAN BIOSCIENCE, INC. · Model 100201 · UDI-DI 00840733101021

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Histoplasma capsulatum antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Histoplasma capsulatum (H. cap.). These reagents are optimized for use in the Ouchterlony double diffusion.

Recalls

Date	Firm	Reason
2019-11-04	Immuno-Mycologics, Inc	False positive results due to potential contamination of reagent.
2016-05-09	Immuno-Mycologics, Inc	The device was found to have bacterial contamination.

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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.