| AllTest Strep A Rapid Test (K260342) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 |
| Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip (K251697) | ACON Laboratories, Inc. | 2025-11-26 |
| Healgen Strep A Rapid Test Strip (Throat Swab) (K212623) | Healgen Scientific,, LLC | 2022-03-16 |
| Sofia Strep A+ FIA, Sofia 2 Analyzer (K171976) | Quidel Corporation | 2017-12-21 |
| SOFIA (R) STREP A+ FIA (K141775) | Quidel Corporation | 2014-12-16 |
| WONDFO RAPID STREP A TEST (K133343) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 |
| SOFIA STREP A FIA (K123793) | Quidel Corporation | 2013-06-17 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP (K122718) | Becton, Dickinson and Company | 2013-02-06 |
| CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489) | Binax, Inc. | 2009-09-04 |
| BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (K082661) | Princeton BioMeditech Corp. | 2008-10-06 |
| INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638) | Unipath , Ltd. | 2005-12-06 |
| STATUS FIRST STREP A (K040708) | Princeton BioMeditech Corp. | 2004-11-22 |
| ACON STREP A RAPID TEST DEVICE (K031784) | ACON Laboratories, Inc. | 2003-07-14 |
| ACON STREP A TWIST TEST DEVICE (K023766) | Acon Laboratories Co. | 2003-02-10 |
| SAS STREPALERT (K023270) | Sa Scientific, Inc. | 2002-10-17 |
| SAS STREPALERT (K013379) | Sa Scientific, Inc. | 2001-12-12 |
| QUICKVUE DIPSTICK STREP A (K011097) | Quidel Corp. | 2001-05-08 |
| ACON STREP A RAPID TEST STRIP (K010582) | Acon Laboratories Co. | 2001-05-07 |
| SAS STREP A TEST (K993456) | Sa Scientific, Inc. | 2000-03-07 |
| OSOM ULTRA STREP A TEST, MODEL 147 (K992658) | Wyntek Diagnostics, Inc. | 2000-01-18 |
| STREP B OIA (K991828) | Biostar, Inc. | 1999-08-19 |
| UNI-GOLD STREP A TEST KIT (K982373) | Trinity Biotech, Plc | 1999-02-11 |
| BIOSTREP A-DIRECT STREP A ANTIGEN TEST (K983386) | Princeton BioMeditech Corp. | 1998-11-25 |
| BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST (K971349) | Princeton BioMeditech Corp. | 1997-07-07 |
| QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS) (K945080) | Quidel Corp. | 1995-02-10 |
| STREP B OIA (K936112) | Biostar, Inc. | 1994-07-06 |
| QTEST(R) STREP (K935667) | Becton Dickinson Advanced Diagnostics | 1994-04-21 |
| BIOSTARS STREP A OIA -- MODIFICATION (K922765) | Biosearch Medical Products, Inc. | 1992-08-20 |
| ABBOTT STREP A CONTROLS (K922490) | Abbott Laboratories | 1992-07-22 |
| SLIDEX STREPTO-KIT (K905020) | Vitek Systems, Inc. | 1991-01-28 |
| KODAK SURECELL(TM) STREP A CONTROL FLUID SET (K904589) | Eastman Kodak Company | 1991-01-18 |
| ICON STREP B IMMUNOENZYMETRIC ASSAY (K902991) | Hybritech, Inc. | 1990-10-03 |
| STREPSLIDE (K882811) | Ncs Diagnostics, Inc. | 1988-10-25 |
| ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL (K864752) | Abbott Laboratories | 1987-02-26 |
| RESPIRASTICK ENZYME IMMUNOASSAY TEST (K862475) | Orion Diagnostica, Inc. | 1986-09-16 |
| HYGEIA RAPID STREP A TEST (K862133) | Hygeia Sciences | 1986-06-25 |
| DIRECTATEX STREP A (K861575) | Pacific Biotech, Inc. | 1986-06-03 |
| STREPTOCOCCUS GR. D (K840511) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| STREPTOCOCCUS PNEUMONIAE CONTROL (K840512) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| STREPTOCOCCUS GR. B CONTROL (K840513) | Scientific Device Laboratory, Inc. | 1984-03-23 |
| PHADEBACT CSF POSITIVE CONTROLS (K840048) | Pharmacia, Inc. | 1984-03-02 |
| PHADEBACT STREP POSITIVE CONTROLS (K832248) | Pharmacia, Inc. | 1983-09-01 |
| MERITEC-STREP GROUP A BETA-HEMOLYTIC (K831599) | Meridian Diagnostics, Inc. | 1983-08-11 |
| BBL DIRECTIGEN TEST KIT (K812808) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-30 |