FDA-Device2026-03-18Class II

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

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
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1559-2026

Original summary

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. Product not cleared by the FDA. Model No. 41972; No UDI; Lot Code: 6933289812337. Distribution: US Nationwide distribution. Affected quantity: 188 units

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