Device product

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Z-1561-2026

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-1561-2026

Official wording

Reason: Product not cleared by the FDA.

Code information: Model No. AL-42153; No UDI; Lot Code: 6952804827274.

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product not cleared by the FDA.