Product Code: GTZ FDA class 1 21 CFR 866.3740

Antisera, All Groups, Streptococcus Spp.

Microbiology

The Antisera, All Groups, Streptococcus Spp. is a set of antisera used in standard serological agglutination methods to identify and group Streptococcus species across all Lancefield antigenic groups, supporting clinical diagnosis and epidemiological surveillance. It is an FDA Class 1 device, the lowest risk category, subject to general controls only and requiring no premarket clearance. The product code is GTZ, regulated under 21 CFR 866.3740 in the Microbiology specialty. No special flags apply to this device.

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510(k)s

105

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GTZ
Device Class: FDA class 1
Regulation Number: 866.3740
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 105 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K012521	BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST	Nov 30, 2001	Substantially Equivalent	Binax, Inc.
K011709	UNI-GOLD STREP A TEST KIT	Nov 08, 2001	Substantially Equivalent	Trinity Biotech, Plc
K010523	MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST	Mar 15, 2001	Substantially Equivalent	Binax, Inc.
K991726	BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI	Aug 27, 1999	Substantially Equivalent	Binax, Inc.
K971522	ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II	Mar 03, 1998	Substantially Equivalent	Abbott Laboratories
K962060	STREP A OIA MAX	Jul 23, 1997	Substantially Equivalent	Biostar, Inc.
K962296	STREPTOLEX-STAT	Dec 16, 1996	Substantially Equivalent	Unipath , Ltd.
K961423	OSOM STREP A TEST	Oct 11, 1996	Substantially Equivalent	Wyntek Diagnostics, Inc.
K962146	EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT	Oct 07, 1996	Substantially Equivalent	Excel Scientific, Inc.
K955108	CARDS Q.S. STREP A	Apr 15, 1996	Substantially Equivalent	Quidel Corp.
K960712	BINAX STREP A TEST	Mar 22, 1996	Substantially Equivalent	Binax, Inc.
K952819	ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)	Jan 26, 1996	Substantially Equivalent	Abbott Laboratories
K954257	QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)	Oct 20, 1995	Substantially Equivalent	Quidel Corp.
K951542	DIRECTIGEN 1-2-3 GROUP A STREP TEST	Oct 20, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K952873	MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)	Sep 08, 1995	Substantially Equivalent	Medix Biotech, Inc.
K935554	QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY	Aug 30, 1995	Substantially Equivalent	Syntron Bioresearch, Inc.
K935475	QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU	Aug 30, 1995	Substantially Equivalent	Syntron Bioresearch, Inc.
K945571	ABBOTT TEST PACK STREP A TEST	Aug 14, 1995	Substantially Equivalent	Abbott Laboratories
K934383	PROLEX (STREPTOCCAL GROUPING LATEX KIT)	Jan 27, 1995	Substantially Equivalent	Pro-Lab, Inc.
K942093	REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST	Nov 28, 1994	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K934484	QUICKVUE IN-LINE ONE-STEP STREP A TEST	Jul 18, 1994	Substantially Equivalent	Quidel Corp.
K932482	MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010	Jul 18, 1994	Substantially Equivalent	Medix Biotech, Inc.
K924461	STREP A NEGATIVE CONTROL	Dec 02, 1993	Substantially Equivalent	Pacific Biotech, Inc.
K924007	QUIKPAC STREP A TEST	Apr 06, 1993	Substantially Equivalent	Syntron Bioresearch, Inc.
K923673	PRECISE STREP A	Sep 28, 1992	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K922345	TESTPACK PLUS STREP A	Jul 16, 1992	Substantially Equivalent	Abbott Laboratories
K920565	BBL STREP GROUPING KIT	Mar 23, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K915758	STREP A OIA	Jan 30, 1992	Substantially Equivalent	Biosearch Medical Products, Inc.
K912889	OIA STREP A	Oct 31, 1991	Substantially Equivalent	Biosearch Medical Products, Inc.
K912868	GROUP A STREP POSITIVE AND NEGATIVE CONTROLS	Aug 07, 1991	Substantially Equivalent	Quidel Corp.
K911417	ICON STREP B IMMUNOENZYMETRIC ASSAY	Jul 24, 1991	Substantially Equivalent	Hybritech, Inc.
K910797	STREPTEX ACID EXTRACTION KIT	Mar 29, 1991	Substantially Equivalent	Wellcome Diagnostics
K903194	REDITEST STREP A TEST KIT	Aug 22, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K902038	PATHO DX STREP D	May 21, 1990	Substantially Equivalent	Diagnostic Products Corp.
K901274	TESTPACK PLUS STREP A	May 11, 1990	Substantially Equivalent	Abbott Laboratories
K896265	QUIDEL GROUP B STREP TEST	Feb 16, 1990	Substantially Equivalent	Quidel Corp.
K897083	VENTRESIGN STREP A TEST	Jan 22, 1990	Substantially Equivalent	Ventrex Laboratories, Inc.
K896221	CARDS O.S.(TM) STREP A	Dec 13, 1989	Substantially Equivalent	Pacific Biotech, Inc.
K896109	IMMUNOCARD STREP A TEST	Nov 29, 1989	Substantially Equivalent	Disease Detection International, Inc.
K895103	ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION	Nov 29, 1989	Substantially Equivalent	Gen-Probe, Inc.
K894711	ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.	Nov 14, 1989	Substantially Equivalent	Gen-Probe, Inc.
K894122	LEECO VIS-DISK STREP-A (EIA)	Aug 15, 1989	Substantially Equivalent	Leeco Diagnostics, Inc.
K893422	CLEARVIEW STREP A	Jun 23, 1989	Substantially Equivalent	Unipath , Ltd.
K890840	VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT	Mar 27, 1989	Substantially Equivalent	Adi Diagnostics, Inc.
K885003	BACTIGEN(R) GROUP B STREPTOCOCCUS TEST	Feb 07, 1989	Substantially Equivalent	Armkel, LLC
K884750	GROUP A STREP, BETA-STREP	Dec 22, 1988	Substantially Equivalent	Ampcor, Inc.
K883999	QUIDEL GROUP A STREP TEST	Oct 12, 1988	Substantially Equivalent	Quidel Corp.
K881457	KODAK SURECELL STREP A TEST KIT	Apr 21, 1988	Substantially Equivalent	Eastman Kodak Company
K880483	V-TREND STREP A TEST	Apr 12, 1988	Substantially Equivalent	Texas Immunology, Inc.
K880460	TARGET STREP A	Mar 03, 1988	Substantially Equivalent	V-Tech, Inc.
K880665	MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT	Mar 01, 1988	Substantially Equivalent	Allelix Diagnostics, Inc.
K874761	RAPID COLORIMETRIC DIRECT STREP A TEST	Feb 19, 1988	Substantially Equivalent	New Horizons Diagnostics Co.
K872904	BINAX EQUATE STREP B	Nov 20, 1987	Substantially Equivalent	Binax, Inc.
K873784	NOVA STREP A	Nov 12, 1987	Substantially Equivalent	Synbiotics Corp.
K872346	SURE-STREP A TEST KIT CATALOG NO. MB-1083	Sep 30, 1987	Substantially Equivalent	Medix Biotech, Inc.
K872961	QTEST STREP	Sep 29, 1987	Substantially Equivalent	Quidel Corp.
K872114	BACTIGEN GROUP B STREPTOCOCCUS-CS TEST	Aug 27, 1987	Substantially Equivalent	Armkel, LLC
K872493	DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST	Aug 24, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871831	PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT	Jun 17, 1987	Substantially Equivalent	Diagnostic Products Corp.
K871620	ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT	Jun 17, 1987	Substantially Equivalent	Allelix, Inc.
K870854	BACTO(R) STREP GROUP KIT	Apr 28, 1987	Substantially Equivalent	Difco Laboratories, Inc.
K870155	DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST	Mar 10, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864170	LEECO VIS-CUBE STREP A (EIA)	Feb 03, 1987	Substantially Equivalent	Leeco Diagnostics, Inc.
K864206	REVEAL COLOUR STREP A ZL16	Jan 13, 1987	Substantially Equivalent	Wellcome Diagnostics
K863908	BINAX STREP A	Dec 22, 1986	Substantially Equivalent	Binax, Inc.
K863647	CARDS(TM) STREP A CATALOG NO. CR-7545	Nov 26, 1986	Substantially Equivalent	Pacific Biotech, Inc.
K861098	SEROIDEN STREPTO KIT 'EIKEN'	Aug 12, 1986	Substantially Equivalent	Syn-Kit, Inc.
K860923	EZ DETECT, 5 MINUTE STREP-A COLOR TEST	May 16, 1986	Substantially Equivalent	Self Care Systems, Inc.
K860947	LEECO-SCREEN, STREP A (EIA)	May 13, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K860768	DIRECTIGEN COMBO MENINGITIS TEST	May 13, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K860778	TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT	Apr 04, 1986	Substantially Equivalent	Hybritech, Inc.
K860576	MUREX SUDS GROUP A STREP	Apr 04, 1986	Substantially Equivalent	Murex Corp.
K854978	DIFCO STREP A LATEX TEST	Mar 18, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K854929	OXOID STREPTOCOCAL GROUPING KIT	Mar 11, 1986	Substantially Equivalent	Oxoid U.S.A., Inc.
K860247	INSTA KIT FOR GROUP A STREP ID	Mar 04, 1986	Substantially Equivalent	Mead Johnson & Co.
K854447	IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST	Jan 03, 1986	Substantially Equivalent	American Micro Scan
K852266	ABBOTT STREP A P.S.D.	Dec 05, 1985	Substantially Equivalent	Abbott Laboratories
K854150	PHADIRECT STREP A TEST	Oct 23, 1985	Substantially Equivalent	Pharmacia, Inc.
K853073	CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.	Aug 01, 1985	Substantially Equivalent	Marion Laboratories, Inc.
K852806	QUIDEL QUEST STREP GROUP A TEST	Jul 30, 1985	Substantially Equivalent	Quidel Corp.
K852841	RAPID DIRECT STREP A LATEX AGGLUTINATION TEST	Jul 24, 1985	Substantially Equivalent	Smithkline Diagnostics, Inc.
K851132	LATEX AGGLUTINATION TEST	Jul 05, 1985	Substantially Equivalent	New Horizons Diagnostics Co.
K850772	BACTIGEN GROUP B STREPTOCOCCUS TEST	May 29, 1985	Substantially Equivalent	Armkel, LLC
K845022	PATHO DX LATEX AGGLUTINATION STREP B KIT	May 02, 1985	Substantially Equivalent	Diagnostic Products Corp.
K850831	STREP A QUICK	Apr 08, 1985	Substantially Equivalent	Abbott Laboratories
K850256	CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES	Apr 08, 1985	Substantially Equivalent	Abbott Laboratories
K844855	VENTRESCREEN STREP A TEST	Jan 16, 1985	Substantially Equivalent	Ventrex Laboratories, Inc.
K844399	RESPIRALEX LATEX AGGLUTINATION TEST	Jan 08, 1985	Substantially Equivalent	Orion Diagnostica, Inc.
K843713	DIRECTIGEN GROUP A STREP TEST KIT	Jan 04, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K844107	PHARMACIA STREP A DIRECT SWAB TEST	Nov 27, 1984	Substantially Equivalent	Pharmacia, Inc.
K843590	DETECT-A-STREP	Oct 30, 1984	Substantially Equivalent	Antibodies, Inc.
K842827	STREPTEX DIRECT A ZL14	Aug 16, 1984	Substantially Equivalent	Wellcome Diagnostics
K842383	PATHO DX LATEX AGGLUTINATION STREP A	Jul 02, 1984	Substantially Equivalent	Diagnostic Products Corp.
K834582	DETECT GROUP A STREP TEST	Apr 04, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K831991	DIRECTIGEN GROUP B STREP TEST KIT-SERUM	Sep 26, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K830445	PHADEBACT STREP F TEST	Apr 27, 1983	Substantially Equivalent	Pharmacia, Inc.
K823569	ABBOTT LABORATORIES STREP A EIA	Mar 01, 1983	Substantially Equivalent	Abbott Laboratories
K821100	MERITECASTREP (TM)	May 13, 1982	Substantially Equivalent	Meridian Diagnostics, Inc.
K820069	WELLCOGEN GROUP B	Feb 18, 1982	Substantially Equivalent	Burroughs Wellcome Co.
K801775	SERO STREP KIT	Oct 10, 1980	Substantially Equivalent	Sacks Farms Biological Products
K801159	STREPTO-SEC TM	Jun 20, 1980	Substantially Equivalent	Organon, Inc.
K800159	PHADEBACT STREP D TEST	Apr 29, 1980	Substantially Equivalent	Pharmacia, Inc.
K790492	SERO-STAT STREPTOCOCCUS TEST	May 01, 1979	Substantially Equivalent	Scott Laboratories, Inc.
K781607	STREP-TEX	Oct 17, 1978	Substantially Equivalent	Burroughs Wellcome Co.
K760033	TEST, ANTIBODIES FOR GRP A, LATEX SLIDE	Aug 03, 1976	Substantially Equivalent	Gamma Biologicals, Inc.