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GTZ — Antisera, All Groups, Streptococcus Spp. Class I

FDA Device Classification

Classification Details

Product Code
GTZ
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
K012521binaxBINAX NOW STREPTOCOCCUS PNEUMONIAE TESTNovember 30, 2001
K011709trinity biotechUNI-GOLD STREP A TEST KITNovember 8, 2001
K010523binaxMODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTMarch 15, 2001
K991726binaxBINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST August 27, 1999
K971522abbott laboratoriesABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIMarch 3, 1998
K962060biostarSTREP A OIA MAXJuly 23, 1997
K962296unipathSTREPTOLEX-STATDecember 16, 1996
K961423wyntek diagnosticsOSOM STREP A TESTOctober 11, 1996
K962146excel scientificEXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITOctober 7, 1996
K955108quidelCARDS Q.S. STREP AApril 15, 1996
K960712binaxBINAX STREP A TESTMarch 22, 1996
K952819abbott laboratoriesABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)January 26, 1996
K954257quidelQUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)October 20, 1995
K951542bd becton dickinson vacutainer systems preanalyticDIRECTIGEN 1-2-3 GROUP A STREP TESTOctober 20, 1995
K952873medix biotechMEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)September 8, 1995
K935554syntron bioresearchQUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAYAugust 30, 1995
K935475syntron bioresearchQUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAUAugust 30, 1995
K945571abbott laboratoriesABBOTT TEST PACK STREP A TESTAugust 14, 1995
K934383pro-labPROLEX (STREPTOCCAL GROUPING LATEX KIT)January 27, 1995
K942093medical diagnostic technologiesREMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TESTNovember 28, 1994