FDA-Device2026-03-18Class II

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

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
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1560-2026

Original summary

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples. Product not cleared by the FDA. Model No. SP-C310343-10; No UDI; Lot Code: 01242573. Distribution: US Nationwide distribution. Affected quantity: 188 units

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