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
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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