Antigens, All Groups, Streptococcus Spp.

FDA product code GTY · 42 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.3740
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1981-12-30 – 2026-04-30

GTY 2026-04-30

AllTest Strep A Rapid Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K number K260342

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GTY 2025-11-26

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Applicant ACON Laboratories, Inc.

K number K251697

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GTY 2022-03-16

Healgen Strep A Rapid Test Strip (Throat Swab)

Applicant Healgen Scientific,, LLC

K number K212623

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GTY 2017-12-21

Sofia Strep A+ FIA, Sofia 2 Analyzer

Applicant Quidel Corporation

K number K171976

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GTY 2013-06-17

SOFIA STREP A FIA

Applicant Quidel Corporation

K number K123793

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GTY 2013-02-06

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP

Applicant Becton, Dickinson and Company

K number K122718

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GTY 2009-09-04

CLEARVIEW ADVANCED STREP A , MODEL 737-430

Applicant Binax, Inc.

K number K091489

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GTY 2008-10-06

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A

Applicant Princeton BioMeditech Corp.

K number K082661

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GTY 2005-12-06

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC

Applicant Unipath , Ltd.

K number K051638

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GTY 2004-11-22

STATUS FIRST STREP A

Applicant Princeton BioMeditech Corp.

K number K040708

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GTY 2003-07-14

ACON STREP A RAPID TEST DEVICE

Applicant ACON Laboratories, Inc.

K number K031784

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GTY 2003-02-10

ACON STREP A TWIST TEST DEVICE

Applicant Acon Laboratories Co.

K number K023766

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GTY 2002-10-17

SAS STREPALERT

Applicant Sa Scientific, Inc.

K number K023270

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GTY 2001-12-12

SAS STREPALERT

Applicant Sa Scientific, Inc.

K number K013379

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GTY 2001-05-08

QUICKVUE DIPSTICK STREP A

Applicant Quidel Corp.

K number K011097

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GTY 2001-05-07

ACON STREP A RAPID TEST STRIP

Applicant Acon Laboratories Co.

K number K010582

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GTY 2000-03-07

SAS STREP A TEST

Applicant Sa Scientific, Inc.

K number K993456

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GTY 2000-01-18

OSOM ULTRA STREP A TEST, MODEL 147

Applicant Wyntek Diagnostics, Inc.

K number K992658

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GTY 1999-08-19

STREP B OIA

Applicant Biostar, Inc.

K number K991828

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GTY 1999-02-11

UNI-GOLD STREP A TEST KIT

Applicant Trinity Biotech, Plc

K number K982373

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GTY 1998-11-25

BIOSTREP A-DIRECT STREP A ANTIGEN TEST

Applicant Princeton BioMeditech Corp.

K number K983386

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GTY 1997-07-07

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

Applicant Princeton BioMeditech Corp.

K number K971349

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GTY 1995-02-10

QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)

Applicant Quidel Corp.

K number K945080

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GTY 1994-07-06

STREP B OIA

Applicant Biostar, Inc.

K number K936112

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GTY 1994-04-21

QTEST(R) STREP

Applicant Becton Dickinson Advanced Diagnostics

K number K935667

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GTY 1992-08-20

BIOSTARS STREP A OIA -- MODIFICATION

Applicant Biosearch Medical Products, Inc.

K number K922765

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GTY 1992-07-22

ABBOTT STREP A CONTROLS

Applicant Abbott Laboratories

K number K922490

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GTY 1991-01-28

SLIDEX STREPTO-KIT

Applicant Vitek Systems, Inc.

K number K905020

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GTY 1991-01-18

KODAK SURECELL(TM) STREP A CONTROL FLUID SET

Applicant Eastman Kodak Company

K number K904589

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GTY 1990-10-03

ICON STREP B IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K902991

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GTY 1988-10-25

STREPSLIDE

Applicant Ncs Diagnostics, Inc.

K number K882811

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GTY 1987-02-26

ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL

Applicant Abbott Laboratories

K number K864752

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GTY 1986-09-16

RESPIRASTICK ENZYME IMMUNOASSAY TEST

Applicant Orion Diagnostica, Inc.

K number K862475

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GTY 1986-06-25

HYGEIA RAPID STREP A TEST

Applicant Hygeia Sciences

K number K862133

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GTY 1986-06-03

DIRECTATEX STREP A

Applicant Pacific Biotech, Inc.

K number K861575

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GTY 1984-03-23

STREPTOCOCCUS GR. B CONTROL

Applicant Scientific Device Laboratory, Inc.

K number K840513

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GTY 1984-03-23

STREPTOCOCCUS PNEUMONIAE CONTROL

Applicant Scientific Device Laboratory, Inc.

K number K840512

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GTY 1984-03-23

STREPTOCOCCUS GR. D

Applicant Scientific Device Laboratory, Inc.

K number K840511

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GTY 1984-03-02

PHADEBACT CSF POSITIVE CONTROLS

Applicant Pharmacia, Inc.

K number K840048

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GTY 1983-09-01

PHADEBACT STREP POSITIVE CONTROLS

Applicant Pharmacia, Inc.

K number K832248

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GTY 1983-08-11

MERITEC-STREP GROUP A BETA-HEMOLYTIC

Applicant Meridian Diagnostics, Inc.

K number K831599

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GTY 1981-12-30

BBL DIRECTIGEN TEST KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K812808

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