Panels › Microbiology › Product code GTY · Class 1
Antigens, All Groups, Streptococcus Spp.
Regulation 866.3740
2510(k)s in 12 months (44 all time)
4recalls in 12 months (20 all time)
8recalls that name a 510(k)
Top companies in GTY
| Company | 510(k)s | Recalls |
|---|---|---|
| Quidel Corp. | 5 | 2 |
| Wondfo USA Co Ltd | 0 | 5 |
| ACON Laboratories, Inc. | 4 | 0 |
| Princeton BioMeditech Corp. | 4 | 0 |
| Altruan GmbH | 0 | 3 |
| Sa Scientific, Inc. | 3 | 0 |
| Scientific Device Laboratory, Inc. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Alere San Diego | 0 | 2 |
| Biostar, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2026 | K260342 | AllTest Strep A Rapid Test Hangzhou AllTest Biotech Co., Ltd., CN | GTY |
| Nov 26, 2025 | K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip ACON Laboratories, Inc. | GTY |
| Mar 16, 2022 | K212623 | Healgen Strep A Rapid Test Strip (Throat Swab) Healgen Scientific,, LLC | GTY |
| Dec 21, 2017 | K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation | GTY |
| Dec 16, 2014 | K141775 | SOFIA (R) STREP A+ FIA Quidel Corporation | GTY |
| Jan 31, 2014 | K133343 | WONDFO RAPID STREP A TEST Guangzhou Wondfo Biotech Co., Ltd. | GTY |
| Jun 17, 2013 | K123793 | SOFIA STREP A FIA Quidel Corporation | GTY |
| Feb 6, 2013 | K122718 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP Becton, Dickinson and Company | GTY |
| Sep 4, 2009 | K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 Binax, Inc. | GTY |
| Oct 6, 2008 | K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A Princeton BioMeditech Corp. | GTY |
| Dec 6, 2005 | K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC Unipath , Ltd., GB | GTY |
| Nov 22, 2004 | K040708 | STATUS FIRST STREP A Princeton BioMeditech Corp. | GTY |
| Jul 14, 2003 | K031784 | ACON STREP A RAPID TEST DEVICE ACON Laboratories, Inc. | GTY |
| Feb 10, 2003 | K023766 | ACON STREP A TWIST TEST DEVICE Acon Laboratories Co. | GTY |
| Oct 17, 2002 | K023270 | SAS STREPALERT Sa Scientific, Inc. | GTY |
| Dec 12, 2001 | K013379 | SAS STREPALERT Sa Scientific, Inc. | GTY |
| May 8, 2001 | K011097 | QUICKVUE DIPSTICK STREP A Quidel Corp. | GTY |
| May 7, 2001 | K010582 | ACON STREP A RAPID TEST STRIP Acon Laboratories Co. | GTY |
| Mar 7, 2000 | K993456 | SAS STREP A TEST Sa Scientific, Inc. | GTY |
| Jan 18, 2000 | K992658 | OSOM ULTRA STREP A TEST, MODEL 147 Wyntek Diagnostics, Inc. | GTY |
| Aug 19, 1999 | K991828 | STREP B OIA Biostar, Inc. | GTY |
| Feb 11, 1999 | K982373 | UNI-GOLD STREP A TEST KIT Trinity Biotech, Plc | GTY |
| Nov 25, 1998 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST Princeton BioMeditech Corp. | GTY |
| Jul 7, 1997 | K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST Princeton BioMeditech Corp. | GTY |
| Feb 10, 1995 | K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) Quidel Corp. | GTY |
| Jul 6, 1994 | K936112 | STREP B OIA Biostar, Inc. | GTY |
| Apr 21, 1994 | K935667 | QTEST(R) STREP Becton Dickinson Advanced Diagnostics | GTY |
| Aug 20, 1992 | K922765 | BIOSTARS STREP A OIA -- MODIFICATION Biosearch Medical Products, Inc. | GTY |
| Jul 22, 1992 | K922490 | ABBOTT STREP A CONTROLS Abbott Laboratories | GTY |
| Jan 28, 1991 | K905020 | SLIDEX STREPTO-KIT Vitek Systems, Inc. | GTY |
| Jan 18, 1991 | K904589 | KODAK SURECELL(TM) STREP A CONTROL FLUID SET Eastman Kodak Company | GTY |
| Oct 3, 1990 | K902991 | ICON STREP B IMMUNOENZYMETRIC ASSAY Hybritech, Inc. | GTY |
| Oct 25, 1988 | K882811 | STREPSLIDE Ncs Diagnostics, Inc., CA | GTY |
| Feb 26, 1987 | K864752 | ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL Abbott Laboratories | GTY |
| Sep 16, 1986 | K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST Orion Diagnostica, Inc. | GTY |
| Jun 25, 1986 | K862133 | HYGEIA RAPID STREP A TEST Hygeia Sciences | GTY |
| Jun 3, 1986 | K861575 | DIRECTATEX STREP A Pacific Biotech, Inc. | GTY |
| Mar 23, 1984 | K840513 | STREPTOCOCCUS GR. B CONTROL Scientific Device Laboratory, Inc. | GTY |
| Mar 23, 1984 | K840512 | STREPTOCOCCUS PNEUMONIAE CONTROL Scientific Device Laboratory, Inc. | GTY |
| Mar 23, 1984 | K840511 | STREPTOCOCCUS GR. D Scientific Device Laboratory, Inc. | GTY |
| Mar 2, 1984 | K840048 | PHADEBACT CSF POSITIVE CONTROLS Pharmacia, Inc. | GTY |
| Sep 1, 1983 | K832248 | PHADEBACT STREP POSITIVE CONTROLS Pharmacia, Inc. | GTY |
| Aug 11, 1983 | K831599 | MERITEC-STREP GROUP A BETA-HEMOLYTIC Meridian Diagnostics, Inc. | GTY |
| Dec 30, 1981 | K812808 | BBL DIRECTIGEN TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GTY |
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