Device product

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

Z-1560-2026

December 19, 2025

Class II

Product summary

Firm: Altruan GmbH
Event: Event 98472
Status: Ongoing
Classification: Class II
Quantity: 188 units
Official record key: device-enforcement:Z-1560-2026

Official wording

Reason: Product not cleared by the FDA.

Code information: Model No. SP-C310343-10; No UDI; Lot Code: 01242573.

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product not cleared by the FDA.