| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
| UNI-GOLD STREP A TEST KIT (K011709) | Trinity Biotech, Plc | 2001-11-08 |
| MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523) | Binax, Inc. | 2001-03-15 |
| BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726) | Binax, Inc. | 1999-08-27 |
| ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522) | Abbott Laboratories | 1998-03-03 |
| STREP A OIA MAX (K962060) | Biostar, Inc. | 1997-07-23 |
| STREPTOLEX-STAT (K962296) | Unipath , Ltd. | 1996-12-16 |
| OSOM STREP A TEST (K961423) | Wyntek Diagnostics, Inc. | 1996-10-11 |
| EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (K962146) | Excel Scientific, Inc. | 1996-10-07 |
| CARDS Q.S. STREP A (K955108) | Quidel Corp. | 1996-04-15 |
| BINAX STREP A TEST (K960712) | Binax, Inc. | 1996-03-22 |
| ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) (K952819) | Abbott Laboratories | 1996-01-26 |
| QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) (K954257) | Quidel Corp. | 1995-10-20 |
| DIRECTIGEN 1-2-3 GROUP A STREP TEST (K951542) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-10-20 |
| MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (K952873) | Medix Biotech, Inc. | 1995-09-08 |
| QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU (K935475) | Syntron Bioresearch, Inc. | 1995-08-30 |
| QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY (K935554) | Syntron Bioresearch, Inc. | 1995-08-30 |
| ABBOTT TEST PACK STREP A TEST (K945571) | Abbott Laboratories | 1995-08-14 |
| PROLEX (STREPTOCCAL GROUPING LATEX KIT) (K934383) | Pro-Lab, Inc. | 1995-01-27 |
| REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST (K942093) | Medical Diagnostic Technologies, Inc. | 1994-11-28 |
| MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (K932482) | Medix Biotech, Inc. | 1994-07-18 |
| QUICKVUE IN-LINE ONE-STEP STREP A TEST (K934484) | Quidel Corp. | 1994-07-18 |
| STREP A NEGATIVE CONTROL (K924461) | Pacific Biotech, Inc. | 1993-12-02 |
| QUIKPAC STREP A TEST (K924007) | Syntron Bioresearch, Inc. | 1993-04-06 |
| PRECISE STREP A (K923673) | Becton Dickinson Advanced Diagnostics | 1992-09-28 |
| TESTPACK PLUS STREP A (K922345) | Abbott Laboratories | 1992-07-16 |
| BBL STREP GROUPING KIT (K920565) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-03-23 |
| STREP A OIA (K915758) | Biosearch Medical Products, Inc. | 1992-01-30 |
| OIA STREP A (K912889) | Biosearch Medical Products, Inc. | 1991-10-31 |
| GROUP A STREP POSITIVE AND NEGATIVE CONTROLS (K912868) | Quidel Corp. | 1991-08-07 |
| ICON STREP B IMMUNOENZYMETRIC ASSAY (K911417) | Hybritech, Inc. | 1991-07-24 |
| STREPTEX ACID EXTRACTION KIT (K910797) | Wellcome Diagnostics | 1991-03-29 |
| REDITEST STREP A TEST KIT (K903194) | Boehringer Mannheim Corp. | 1990-08-22 |
| PATHO DX STREP D (K902038) | Diagnostic Products Corp. | 1990-05-21 |
| TESTPACK PLUS STREP A (K901274) | Abbott Laboratories | 1990-05-11 |
| QUIDEL GROUP B STREP TEST (K896265) | Quidel Corp. | 1990-02-16 |
| VENTRESIGN STREP A TEST (K897083) | Ventrex Laboratories, Inc. | 1990-01-22 |
| CARDS O.S.(TM) STREP A (K896221) | Pacific Biotech, Inc. | 1989-12-13 |
| IMMUNOCARD STREP A TEST (K896109) | Disease Detection International, Inc. | 1989-11-29 |
| ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION (K895103) | Gen-Probe, Inc. | 1989-11-29 |
| ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA. (K894711) | Gen-Probe, Inc. | 1989-11-14 |
| LEECO VIS-DISK STREP-A (EIA) (K894122) | Leeco Diagnostics, Inc. | 1989-08-15 |
| CLEARVIEW STREP A (K893422) | Unipath , Ltd. | 1989-06-23 |
| VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT (K890840) | Adi Diagnostics, Inc. | 1989-03-27 |
| BACTIGEN(R) GROUP B STREPTOCOCCUS TEST (K885003) | Armkel, LLC | 1989-02-07 |
| GROUP A STREP, BETA-STREP (K884750) | Ampcor, Inc. | 1988-12-22 |
| QUIDEL GROUP A STREP TEST (K883999) | Quidel Corp. | 1988-10-12 |
| KODAK SURECELL STREP A TEST KIT (K881457) | Eastman Kodak Company | 1988-04-21 |
| V-TREND STREP A TEST (K880483) | Texas Immunology, Inc. | 1988-04-12 |
| TARGET STREP A (K880460) | V-Tech, Inc. | 1988-03-03 |
| MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT (K880665) | Allelix Diagnostics, Inc. | 1988-03-01 |
| RAPID COLORIMETRIC DIRECT STREP A TEST (K874761) | New Horizons Diagnostics Co. | 1988-02-19 |
| BINAX EQUATE STREP B (K872904) | Binax, Inc. | 1987-11-20 |
| NOVA STREP A (K873784) | Synbiotics Corp. | 1987-11-12 |
| SURE-STREP A TEST KIT CATALOG NO. MB-1083 (K872346) | Medix Biotech, Inc. | 1987-09-30 |
| QTEST STREP (K872961) | Quidel Corp. | 1987-09-29 |
| BACTIGEN GROUP B STREPTOCOCCUS-CS TEST (K872114) | Armkel, LLC | 1987-08-27 |
| DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST (K872493) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-08-24 |
| PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT (K871831) | Diagnostic Products Corp. | 1987-06-17 |
| ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT (K871620) | Allelix, Inc. | 1987-06-17 |
| BACTO(R) STREP GROUP KIT (K870854) | Difco Laboratories, Inc. | 1987-04-28 |
| DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST (K870155) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-10 |
| LEECO VIS-CUBE STREP A (EIA) (K864170) | Leeco Diagnostics, Inc. | 1987-02-03 |
| REVEAL COLOUR STREP A ZL16 (K864206) | Wellcome Diagnostics | 1987-01-13 |
| BINAX STREP A (K863908) | Binax, Inc. | 1986-12-22 |
| CARDS(TM) STREP A CATALOG NO. CR-7545 (K863647) | Pacific Biotech, Inc. | 1986-11-26 |
| SEROIDEN STREPTO KIT 'EIKEN' (K861098) | Syn-Kit, Inc. | 1986-08-12 |
| EZ DETECT, 5 MINUTE STREP-A COLOR TEST (K860923) | Self Care Systems, Inc. | 1986-05-16 |
| DIRECTIGEN COMBO MENINGITIS TEST (K860768) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-05-13 |
| LEECO-SCREEN, STREP A (EIA) (K860947) | Leeco Diagnostics, Inc. | 1986-05-13 |
| MUREX SUDS GROUP A STREP (K860576) | Murex Corp. | 1986-04-04 |
| TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT (K860778) | Hybritech, Inc. | 1986-04-04 |
| DIFCO STREP A LATEX TEST (K854978) | Difco Laboratories, Inc. | 1986-03-18 |
| OXOID STREPTOCOCAL GROUPING KIT (K854929) | Oxoid U.S.A., Inc. | 1986-03-11 |
| INSTA KIT FOR GROUP A STREP ID (K860247) | Mead Johnson & Co. | 1986-03-04 |
| IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST (K854447) | American Micro Scan | 1986-01-03 |
| ABBOTT STREP A P.S.D. (K852266) | Abbott Laboratories | 1985-12-05 |
| PHADIRECT STREP A TEST (K854150) | Pharmacia, Inc. | 1985-10-23 |
| CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (K853073) | Marion Laboratories, Inc. | 1985-08-01 |
| QUIDEL QUEST STREP GROUP A TEST (K852806) | Quidel Corp. | 1985-07-30 |
| RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (K852841) | Smithkline Diagnostics, Inc. | 1985-07-24 |
| LATEX AGGLUTINATION TEST (K851132) | New Horizons Diagnostics Co. | 1985-07-05 |
| BACTIGEN GROUP B STREPTOCOCCUS TEST (K850772) | Armkel, LLC | 1985-05-29 |
| PATHO DX LATEX AGGLUTINATION STREP B KIT (K845022) | Diagnostic Products Corp. | 1985-05-02 |
| CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES (K850256) | Abbott Laboratories | 1985-04-08 |
| STREP A QUICK (K850831) | Abbott Laboratories | 1985-04-08 |
| VENTRESCREEN STREP A TEST (K844855) | Ventrex Laboratories, Inc. | 1985-01-16 |
| RESPIRALEX LATEX AGGLUTINATION TEST (K844399) | Orion Diagnostica, Inc. | 1985-01-08 |
| DIRECTIGEN GROUP A STREP TEST KIT (K843713) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-04 |
| PHARMACIA STREP A DIRECT SWAB TEST (K844107) | Pharmacia, Inc. | 1984-11-27 |
| DETECT-A-STREP (K843590) | Antibodies, Inc. | 1984-10-30 |
| STREPTEX DIRECT A ZL14 (K842827) | Wellcome Diagnostics | 1984-08-16 |
| PATHO DX LATEX AGGLUTINATION STREP A (K842383) | Diagnostic Products Corp. | 1984-07-02 |
| DETECT GROUP A STREP TEST (K834582) | Difco Laboratories, Inc. | 1984-04-04 |
| DIRECTIGEN GROUP B STREP TEST KIT-SERUM (K831991) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 |
| PHADEBACT STREP F TEST (K830445) | Pharmacia, Inc. | 1983-04-27 |
| ABBOTT LABORATORIES STREP A EIA (K823569) | Abbott Laboratories | 1983-03-01 |
| MERITECASTREP (TM) (K821100) | Meridian Diagnostics, Inc. | 1982-05-13 |
| WELLCOGEN GROUP B (K820069) | Burroughs Wellcome Co. | 1982-02-18 |
| SERO STREP KIT (K801775) | Sacks Farms Biological Products | 1980-10-10 |