FDA-Device2026-03-18Class II
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Altruan GmbH
Hazard
Product not cleared by the FDA.
Sold states
US Nationwide distribution.
Affected count
188 units
Manufactured in
Morolding 6, N/A, Massing, N/A, Germany
Products
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2026Original summary
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs. Product not cleared by the FDA. Model No. AL-42153; No UDI; Lot Code: 6952804827274. Distribution: US Nationwide distribution. Affected quantity: 188 units
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