6 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
FDA Enforcement
Class II
·Ongoing·Altruan GmbH·March 18, 2026
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
FDA Enforcement
Class II
·Ongoing·Altruan GmbH·March 18, 2026
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
FDA Enforcement
Class II
·Ongoing·Altruan GmbH·March 18, 2026
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
FDA Recall
Open, Classified
·Altruan GmbH Morolding 6 Massing Germany·Product code GTY·December 19, 2025
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
FDA Recall
Open, Classified
·Altruan GmbH Morolding 6 Massing Germany·Product code GTY·December 19, 2025
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
FDA Recall
Open, Classified
·Altruan GmbH Morolding 6 Massing Germany·Product code GTY·December 19, 2025