Antisera, All Groups, Streptococcus Spp.
FDA product code GTZ · Class I (low risk) · 21 CFR 866.3740 · Microbiology
105510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Abbott Laboratories 9
- Quidel Corp. 8
- Bd Becton Dickinson Vacutainer Systems Preanalytic 7
- Binax, Inc. 6
- Pharmacia, Inc. 4
- Diagnostic Products Corp. 4
- Pacific Biotech, Inc. 3
- Leeco Diagnostics, Inc. 3
- Syntron Bioresearch, Inc. 3
- Difco Laboratories, Inc. 3
- Wellcome Diagnostics 3
- Medix Biotech, Inc. 3
- Armkel, LLC 3
- Hybritech, Inc. 2
- Biosearch Medical Products, Inc. 2
- New Horizons Diagnostics Co. 2
- Ventrex Laboratories, Inc. 2
- Unipath , Ltd. 2
- Gen-Probe, Inc. 2
- Burroughs Wellcome Co. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012521 | Binax Now Streptococcus Pneumoniae TestGTZ · Traditional | Binax, Inc. | 11/30/2001SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | Trinity Biotech, Plc | 11/08/2001SE |
| K010523 | Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestGTZ · Special | Binax, Inc. | 03/15/2001SE |
| K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional | Binax, Inc. | 08/27/1999SE |
| K971522 | Abbott Testpack Plus Strep a with on Board Controls (Obc) IIGTZ · Traditional | Abbott Laboratories | 03/03/1998SE |
| K962060 | Strep a Oia MaxGTZ · Traditional | Biostar, Inc. | 07/23/1997SE |
| K962296 | Streptolex-StatGTZ · Traditional | Unipath , Ltd. | 12/16/1996SE |
| K961423 | Osom Strep a TestGTZ · Traditional | Wyntek Diagnostics, Inc. | 10/11/1996SE |
| K962146 | Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional | Excel Scientific, Inc. | 10/07/1996SE |
| K955108 | Cards Q.S. Strep aGTZ · Traditional | Quidel Corp. | 04/15/1996SE |
| K960712 | Binax Strep a TestGTZ · Traditional | Binax, Inc. | 03/22/1996SE |
| K952819 | Abbott Testpack Plus Strep a with on Board Controls (Obc)GTZ · Traditional | Abbott Laboratories | 01/26/1996SE |
| K954257 | Quickvue In-Line One Step Strep a Test (Modification)GTZ · Traditional | Quidel Corp. | 10/20/1995SE |
| K951542 | Directigen 1-2-3 Group a Strep TestGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/20/1995SE |
| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | Medix Biotech, Inc. | 09/08/1995SE |
| K935554 | Quikpac II Onestep Strep a Immunochromatographic AssayGTZ · Traditional | Syntron Bioresearch, Inc. | 08/30/1995SE |
| K935475 | Quikstrip Onestep Strep a Test Immunochroma AssauGTZ · Traditional | Syntron Bioresearch, Inc. | 08/30/1995SE |
| K945571 | Abbott Test Pack Strep a TestGTZ · Traditional | Abbott Laboratories | 08/14/1995SE |
| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | Pro-Lab, Inc. | 01/27/1995SE |
| K942093 | Remel Rim Streptococcus Grouping Latex Agglutination TestGTZ · Traditional | Medical Diagnostic Technologies, Inc. | 11/28/1994SE |
| K934484 | Quickvue In-Line One-Step Strep a TestGTZ · Traditional | Quidel Corp. | 07/18/1994SE |
| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | Medix Biotech, Inc. | 07/18/1994SE |
| K924461 | Strep a Negative ControlGTZ · Traditional | Pacific Biotech, Inc. | 12/02/1993SE |
| K924007 | Quikpac Strep a TestGTZ · Traditional | Syntron Bioresearch, Inc. | 04/06/1993SE |
| K923673 | Precise Strep aGTZ · Traditional | Becton Dickinson Advanced Diagnostics | 09/28/1992SE |
| K922345 | Testpack Plus Strep aGTZ · Traditional | Abbott Laboratories | 07/16/1992SE |
| K920565 | BBL Strep Grouping KitGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K915758 | Strep a OiaGTZ · Traditional | Biosearch Medical Products, Inc. | 01/30/1992SE |
| K912889 | Oia Strep aGTZ · Traditional | Biosearch Medical Products, Inc. | 10/31/1991SE |
| K912868 | Group a Strep Positive and Negative ControlsGTZ · Traditional | Quidel Corp. | 08/07/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | Hybritech, Inc. | 07/24/1991SE |
| K910797 | Streptex Acid Extraction KitGTZ · Traditional | Wellcome Diagnostics | 03/29/1991SE |
| K903194 | Reditest Strep a Test KitGTZ · Traditional | Boehringer Mannheim Corp. | 08/22/1990SE |
| K902038 | Patho DX Strep DGTZ · Traditional | Diagnostic Products Corp. | 05/21/1990SE |
| K901274 | Testpack Plus Strep aGTZ · Traditional | Abbott Laboratories | 05/11/1990SE |
| K896265 | Quidel Group B Strep TestGTZ · Traditional | Quidel Corp. | 02/16/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | Ventrex Laboratories, Inc. | 01/22/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | Pacific Biotech, Inc. | 12/13/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | Disease Detection International, Inc. | 11/29/1989SE |
| K895103 | Accuprobe Enterococcus Culture ConfirmationGTZ · Traditional | Gen-Probe, Inc. | 11/29/1989SE |
| K894711 | Accuprobe Group B Streptococcus Culture Confirma.GTZ · Traditional | Gen-Probe, Inc. | 11/14/1989SE |
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | Leeco Diagnostics, Inc. | 08/15/1989SE |
| K893422 | Clearview Strep aGTZ · Traditional | Unipath , Ltd. | 06/23/1989SE |
| K890840 | Visuwell Group a Streptococcus Detection KitGTZ · Traditional | Adi Diagnostics, Inc. | 03/27/1989SE |
| K885003 | Bactigen(R) Group B Streptococcus TestGTZ · Traditional | Armkel, LLC | 02/07/1989SE |
| K884750 | Group a Strep, Beta-StrepGTZ · Traditional | Ampcor, Inc. | 12/22/1988SE |
| K883999 | Quidel Group a Strep TestGTZ · Traditional | Quidel Corp. | 10/12/1988SE |
| K881457 | Kodak Surecell Strep a Test KitGTZ · Traditional | Eastman Kodak Company | 04/21/1988SE |
| K880483 | V-Trend Strep a TestGTZ · Traditional | Texas Immunology, Inc. | 04/12/1988SE |
| K880460 | Target Strep aGTZ · Traditional | V-Tech, Inc. | 03/03/1988SE |
| K880665 | Modified Group a Streptococcus Detection KitGTZ · Traditional | Allelix Diagnostics, Inc. | 03/01/1988SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | New Horizons Diagnostics Co. | 02/19/1988SE |
| K872904 | Binax Equate Strep BGTZ · Traditional | Binax, Inc. | 11/20/1987SE |
| K873784 | Nova Strep aGTZ · Traditional | Synbiotics Corp. | 11/12/1987SE |
| K872346 | Sure-Strep a Test Kit Catalog No. MB-1083GTZ · Traditional | Medix Biotech, Inc. | 09/30/1987SE |
| K872961 | Qtest StrepGTZ · Traditional | Quidel Corp. | 09/29/1987SE |
| K872114 | Bactigen Group B Streptococcus-Cs TestGTZ · Traditional | Armkel, LLC | 08/27/1987SE |
| K872493 | Directigen 1-2-3(TM) Group a Strep TestGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/24/1987SE |
| K871831 | Patho DX Latex Agglutination Strep Grouping KitGTZ · Traditional | Diagnostic Products Corp. | 06/17/1987SE |
| K871620 | Allelix Group a Streptococcus Detection KitGTZ · Traditional | Allelix, Inc. | 06/17/1987SE |
| K870854 | Bacto(R) Strep Group KitGTZ · Traditional | Difco Laboratories, Inc. | 04/28/1987SE |
| K870155 | Directigen Meningitis Combo Test & (B) Strep TestGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | Leeco Diagnostics, Inc. | 02/03/1987SE |
| K864206 | Reveal Colour Strep a ZL16GTZ · Traditional | Wellcome Diagnostics | 01/13/1987SE |
| K863908 | Binax Strep aGTZ · Traditional | Binax, Inc. | 12/22/1986SE |
| K863647 | Cards(Tm) Strep a Catalog No. CR-7545GTZ · Traditional | Pacific Biotech, Inc. | 11/26/1986SE |
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | Syn-Kit, Inc. | 08/12/1986SE |
| K860923 | Ez Detect, 5 Minute Strep-A Color TestGTZ · Traditional | Self Care Systems, Inc. | 05/16/1986SE |
| K860947 | Leeco-Screen, Strep a (Eia)GTZ · Traditional | Leeco Diagnostics, Inc. | 05/13/1986SE |
| K860768 | Directigen Combo Meningitis TestGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1986SE |
| K860778 | Tandem Icon Strep a Immunoenzymetric Assay KitGTZ · Traditional | Hybritech, Inc. | 04/04/1986SE |
| K860576 | Murex Suds Group a StrepGTZ · Traditional | Murex Corp. | 04/04/1986SE |
| K854978 | Difco Strep a Latex TestGTZ · Traditional | Difco Laboratories, Inc. | 03/18/1986SE |
| K854929 | Oxoid Streptococal Grouping KitGTZ · Traditional | Oxoid U.S.A., Inc. | 03/11/1986SE |
| K860247 | Insta Kit for Group a Strep IdGTZ · Traditional | Mead Johnson & Co. | 03/04/1986SE |
| K854447 | Immunoscan Rapid Direct Group a Strep TestGTZ · Traditional | American Micro Scan | 01/03/1986SE |
| K852266 | Abbott Strep a P.S.D.GTZ · Traditional | Abbott Laboratories | 12/05/1985SE |
| K854150 | Phadirect Strep a TestGTZ · Traditional | Pharmacia, Inc. | 10/23/1985SE |
| K853073 | Culturette Brand 10-MINUTE Group a Strep I.D.GTZ · Traditional | Marion Laboratories, Inc. | 08/01/1985SE |
| K852806 | Quidel Quest Strep Group a TestGTZ · Traditional | Quidel Corp. | 07/30/1985SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | Smithkline Diagnostics, Inc. | 07/24/1985SE |
| K851132 | Latex Agglutination TestGTZ · Traditional | New Horizons Diagnostics Co. | 07/05/1985SE |
| K850772 | Bactigen Group B Streptococcus TestGTZ · Traditional | Armkel, LLC | 05/29/1985SE |
| K845022 | Patho DX Latex Agglutination Strep B KitGTZ · Traditional | Diagnostic Products Corp. | 05/02/1985SE |
| K850831 | Strep a QuickGTZ · Traditional | Abbott Laboratories | 04/08/1985SE |
| K850256 | Confirm Immunoassay for Detecttion Strep-PyogenesGTZ · Traditional | Abbott Laboratories | 04/08/1985SE |
| K844855 | Ventrescreen Strep a TestGTZ · Traditional | Ventrex Laboratories, Inc. | 01/16/1985SE |
| K844399 | Respiralex Latex Agglutination TestGTZ · Traditional | Orion Diagnostica, Inc. | 01/08/1985SE |
| K843713 | Directigen Group a Strep Test KitGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/04/1985SE |
| K844107 | Pharmacia Strep a Direct Swab TestGTZ · Traditional | Pharmacia, Inc. | 11/27/1984SE |
| K843590 | Detect-A-StrepGTZ · Traditional | Antibodies, Inc. | 10/30/1984SE |
| K842827 | Streptex Direct a ZL14GTZ · Traditional | Wellcome Diagnostics | 08/16/1984SE |
| K842383 | Patho DX Latex Agglutination Strep aGTZ · Traditional | Diagnostic Products Corp. | 07/02/1984SE |
| K834582 | Detect Group a Strep TestGTZ · Traditional | Difco Laboratories, Inc. | 04/04/1984SE |
| K831991 | Directigen Group B Strep Test Kit-SerumGTZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/26/1983SE |
| K830445 | Phadebact Strep F TestGTZ · Traditional | Pharmacia, Inc. | 04/27/1983SE |
| K823569 | Abbott Laboratories Strep a EiaGTZ · Traditional | Abbott Laboratories | 03/01/1983SE |
| K821100 | Meritecastrep (TM)GTZ · Traditional | Meridian Diagnostics, Inc. | 05/13/1982SE |
| K820069 | Wellcogen Group BGTZ · Traditional | Burroughs Wellcome Co. | 02/18/1982SE |
| K801775 | Sero Strep KitGTZ · Traditional | Sacks Farms Biological Products | 10/10/1980SE |
| K801159 | Strepto-Sec TMGTZ · Traditional | Organon, Inc. | 06/20/1980SE |
| K800159 | Phadebact Strep D TestGTZ · Traditional | Pharmacia, Inc. | 04/29/1980SE |
| K790492 | Sero-Stat Streptococcus TestGTZ · Traditional | Scott Laboratories, Inc. | 05/01/1979SE |
| K781607 | Strep-TexGTZ · Traditional | Burroughs Wellcome Co. | 10/17/1978SE |
| K760033 | Test, Antibodies for GRP a, Latex SlideGTZ · Traditional | Gamma Biologicals, Inc. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3184-2024 Class II | BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025Due to a classification error in our inventory management system, these medical devices were shipped to… | Cypress Medical Products LLC | 08/20/2024Open, Classified |
| Z-1506-2009 | Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in…Potential for false positive Strep A results. | Binax, Inc. dba IMPD | 04/06/2009Terminated |