FDA-Device2025-03-26Class II
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Immuno-Mycologics, Inc
Hazard
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Sold states
Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.
Affected count
30 vials
Manufactured in
2701 Corporate Centre Dr, N/A, Norman, OK, United States
Products
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2025Don't want to check this manually?
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