GTZ · Class I · 21 CFR 866.3740

FDA Product Code GTZ: Antisera, All Groups, Streptococcus Spp.

Leading manufacturers include Abbott Laboratories, Quidel Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

105
Total
105
Cleared
106d
Avg days
1976
Since
105 devices
49–72 of 105
Cleared Sep 29, 1987
QTEST STREP
K872961
Quidel Corp.
Microbiology · 62d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114
Armkel, LLC
Microbiology · 87d
Cleared Aug 24, 1987
DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST
K872493
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 62d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831
Diagnostic Products Corp.
Microbiology · 37d
Cleared Apr 28, 1987
BACTO(R) STREP GROUP KIT
K870854
Difco Laboratories, Inc.
Microbiology · 56d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 56d
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170
Leeco Diagnostics, Inc.
Microbiology · 102d
Cleared Jan 13, 1987
REVEAL COLOUR STREP A ZL16
K864206
Wellcome Diagnostics
Microbiology · 78d
Cleared Dec 22, 1986
BINAX STREP A
K863908
Binax, Inc.
Microbiology · 76d
Cleared Nov 26, 1986
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647
Pacific Biotech, Inc.
Microbiology · 69d
Cleared Aug 12, 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098
Syn-Kit, Inc.
Microbiology · 141d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 71d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947
Leeco Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778
Hybritech, Inc.
Microbiology · 32d
Cleared Mar 18, 1986
DIFCO STREP A LATEX TEST
K854978
Difco Laboratories, Inc.
Microbiology · 96d
Cleared Mar 11, 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929
Oxoid U.S.A., Inc.
Microbiology · 91d
Cleared Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447
American Micro Scan
Microbiology · 59d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266
Abbott Laboratories
Microbiology · 191d
Cleared Oct 23, 1985
PHADIRECT STREP A TEST
K854150
Pharmacia, Inc.
Microbiology · 12d
Cleared Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073
Marion Laboratories, Inc.
Microbiology · 9d
Cleared Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
K852806
Quidel Corp.
Immunology · 27d
Cleared Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841
Smithkline Diagnostics, Inc.
Microbiology · 19d
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772
Armkel, LLC
Microbiology · 93d
Cleared May 02, 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
K845022
Diagnostic Products Corp.
Microbiology · 126d