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GTY — Antigens, All Groups, Streptococcus Spp. Class I

FDA Device Classification

Classification Details

Product Code
GTY
Device Class
Class I
Regulation Number
866.3740
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251697acon laboratoriesFlowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StNovember 26, 2025
K212623healgen scientificHealgen Strep A Rapid Test Strip (Throat Swab)March 16, 2022
K171976quidel corporationSofia Strep A+ FIA, Sofia 2 AnalyzerDecember 21, 2017
K141775quidel corporationSOFIA (R) STREP A+ FIADecember 16, 2014
K133343guangzhou wondfo biotech coWONDFO RAPID STREP A TESTJanuary 31, 2014
K123793quidel corporationSOFIA STREP A FIAJune 17, 2013
K122718becton, dickinson andBD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPFebruary 6, 2013
K091489binaxCLEARVIEW ADVANCED STREP A , MODEL 737-430September 4, 2009
K082661princeton biomeditechBIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP AOctober 6, 2008
K051638unipathINVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCDecember 6, 2005
K040708princeton biomeditechSTATUS FIRST STREP ANovember 22, 2004
K031784acon laboratoriesACON STREP A RAPID TEST DEVICEJuly 14, 2003
K023766acon laboratoriesACON STREP A TWIST TEST DEVICEFebruary 10, 2003
K023270sa scientificSAS STREPALERTOctober 17, 2002
K013379sa scientificSAS STREPALERTDecember 12, 2001
K011097quidelQUICKVUE DIPSTICK STREP AMay 8, 2001
K010582acon laboratoriesACON STREP A RAPID TEST STRIPMay 7, 2001
K993456sa scientificSAS STREP A TESTMarch 7, 2000
K992658wyntek diagnosticsOSOM ULTRA STREP A TEST, MODEL 147January 18, 2000
K991828biostarSTREP B OIAAugust 19, 1999