FDA-Device2016-06-29Class II
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Immuno-Mycologics, Inc
Hazard
The device was found to have bacterial contamination.
Sold states
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Affected count
467 units
Manufactured in
2700 Technology Pl, N/A, Norman, OK, United States
Products
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2016Don't want to check this manually?
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