Panels › Microbiology › Product code GTZ · Class 1
Antisera, All Groups, Streptococcus Spp.
Regulation 866.3740
0510(k)s in 12 months (105 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GTZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 1988 | K880665 | MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT Allelix Diagnostics, Inc., CA | GTZ |
| Feb 19, 1988 | K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST New Horizons Diagnostics Co. | GTZ |
| Nov 20, 1987 | K872904 | BINAX EQUATE STREP B Binax, Inc. | GTZ |
| Nov 12, 1987 | K873784 | NOVA STREP A Synbiotics Corp. | GTZ |
| Sep 30, 1987 | K872346 | SURE-STREP A TEST KIT CATALOG NO. MB-1083 Medix Biotech, Inc. | GTZ |
| Sep 29, 1987 | K872961 | QTEST STREP Quidel Corp. | GTZ |
| Aug 27, 1987 | K872114 | BACTIGEN GROUP B STREPTOCOCCUS-CS TEST Armkel, LLC | GTZ |
| Aug 24, 1987 | K872493 | DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GTZ |
| Jun 17, 1987 | K871831 | PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT Diagnostic Products Corp. | GTZ |
| Jun 17, 1987 | K871620 | ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT Allelix, Inc., CA | GTZ |
| Apr 28, 1987 | K870854 | BACTO(R) STREP GROUP KIT Difco Laboratories, Inc. | GTZ |
| Mar 10, 1987 | K870155 | DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GTZ |
| Feb 3, 1987 | K864170 | LEECO VIS-CUBE STREP A (EIA) Leeco Diagnostics, Inc. | GTZ |
| Jan 13, 1987 | K864206 | REVEAL COLOUR STREP A ZL16 Wellcome Diagnostics | GTZ |
| Dec 22, 1986 | K863908 | BINAX STREP A Binax, Inc. | GTZ |
| Nov 26, 1986 | K863647 | CARDS(TM) STREP A CATALOG NO. CR-7545 Pacific Biotech, Inc. | GTZ |
| Aug 12, 1986 | K861098 | SEROIDEN STREPTO KIT 'EIKEN' Syn-Kit, Inc. | GTZ |
| May 16, 1986 | K860923 | EZ DETECT, 5 MINUTE STREP-A COLOR TEST Self Care Systems, Inc. | GTZ |
| May 13, 1986 | K860947 | LEECO-SCREEN, STREP A (EIA) Leeco Diagnostics, Inc. | GTZ |
| May 13, 1986 | K860768 | DIRECTIGEN COMBO MENINGITIS TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | GTZ |
| Apr 4, 1986 | K860778 | TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. | GTZ |
| Apr 4, 1986 | K860576 | MUREX SUDS GROUP A STREP Murex Corp. | GTZ |
| Mar 18, 1986 | K854978 | DIFCO STREP A LATEX TEST Difco Laboratories, Inc. | GTZ |
| Mar 11, 1986 | K854929 | OXOID STREPTOCOCAL GROUPING KIT Oxoid U.S.A., Inc. | GTZ |
| Mar 4, 1986 | K860247 | INSTA KIT FOR GROUP A STREP ID Mead Johnson & Co. | GTZ |
| Jan 3, 1986 | K854447 | IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST American Micro Scan | GTZ |
| Dec 5, 1985 | K852266 | ABBOTT STREP A P.S.D. Abbott Laboratories | GTZ |
| Oct 23, 1985 | K854150 | PHADIRECT STREP A TEST Pharmacia, Inc. | GTZ |
| Aug 1, 1985 | K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. Marion Laboratories, Inc. | GTZ |
| Jul 30, 1985 | K852806 | QUIDEL QUEST STREP GROUP A TEST Quidel Corp. | GTZ |
| Jul 24, 1985 | K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST Smithkline Diagnostics, Inc. | GTZ |
| Jul 5, 1985 | K851132 | LATEX AGGLUTINATION TEST New Horizons Diagnostics Co. | GTZ |
| May 29, 1985 | K850772 | BACTIGEN GROUP B STREPTOCOCCUS TEST Armkel, LLC | GTZ |
| May 2, 1985 | K845022 | PATHO DX LATEX AGGLUTINATION STREP B KIT Diagnostic Products Corp. | GTZ |
| Apr 8, 1985 | K850831 | STREP A QUICK Abbott Laboratories | GTZ |
| Apr 8, 1985 | K850256 | CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES Abbott Laboratories | GTZ |
| Jan 16, 1985 | K844855 | VENTRESCREEN STREP A TEST Ventrex Laboratories, Inc. | GTZ |
| Jan 8, 1985 | K844399 | RESPIRALEX LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | GTZ |
| Jan 4, 1985 | K843713 | DIRECTIGEN GROUP A STREP TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GTZ |
| Nov 27, 1984 | K844107 | PHARMACIA STREP A DIRECT SWAB TEST Pharmacia, Inc. | GTZ |
| Oct 30, 1984 | K843590 | DETECT-A-STREP Antibodies, Inc. | GTZ |
| Aug 16, 1984 | K842827 | STREPTEX DIRECT A ZL14 Wellcome Diagnostics | GTZ |
| Jul 2, 1984 | K842383 | PATHO DX LATEX AGGLUTINATION STREP A Diagnostic Products Corp. | GTZ |
| Apr 4, 1984 | K834582 | DETECT GROUP A STREP TEST Difco Laboratories, Inc. | GTZ |
| Sep 26, 1983 | K831991 | DIRECTIGEN GROUP B STREP TEST KIT-SERUM Bd Becton Dickinson Vacutainer Systems Preanalytic | GTZ |
| Apr 27, 1983 | K830445 | PHADEBACT STREP F TEST Pharmacia, Inc. | GTZ |
| Mar 1, 1983 | K823569 | ABBOTT LABORATORIES STREP A EIA Abbott Laboratories | GTZ |
| May 13, 1982 | K821100 | MERITECASTREP (TM) Meridian Diagnostics, Inc. | GTZ |
| Feb 18, 1982 | K820069 | WELLCOGEN GROUP B Burroughs Wellcome Co. | GTZ |
| Oct 10, 1980 | K801775 | SERO STREP KIT Sacks Farms Biological Products | GTZ |
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