Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

69 devices · GMDN 51707

This category includes in vitro diagnostic kits designed for the rapid detection of antigens from Group A beta-hemolytic Streptococcus bacteria in clinical specimens. These tests are typically performed in a laboratory or point-of-care setting to provide results much faster than standard laboratory procedures.

These kits are supplied as a collection of reagents and associated materials intended for qualitative and/or semi-quantitative analysis. They are not intended for self-testing and are used to support clinical decision-making regarding the presence of the bacteria.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category

Clearview®
Alere San Diego, Inc. Class I
McKesson
MCKESSON MEDICAL-SURGICAL INC. Class I
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Beckman Coulter, Inc. Class I
Status Strep A Flip
PRINCETON BIOMEDITECH CORP. Class I
Status Strep A Flip
PRINCETON BIOMEDITECH CORP. Class I
Status Strep A Plus
PRINCETON BIOMEDITECH CORP. Class I
Accutest Value+ Strep A Rapid Test Strip
JANT PHARMACAL CORP. Class I
Henry Schein
HENRY SCHEIN, INC. Class I
Wondview
WONDFO USA CO., LTD. Class I
McKesson
MCKESSON MEDICAL-SURGICAL INC. Class I
BioSign® Strep A Flip
PRINCETON BIOMEDITECH CORP. Class I
BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit
BECTON DICKINSON AND COMPANY Class I
Henry Schein
HENRY SCHEIN, INC. Class I
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Beckman Coulter, Inc. Class I
QuSTICK™ Strep A
STANBIO LABORATORY, L.P. Class I
BinaxNOW Strep A Card
Alere Scarborough, Inc. Class I
Status Strep A strip
PRINCETON BIOMEDITECH CORP. Class I
Sure-Vue
FISHER SCIENTIFIC COMPANY L.L.C. Class I
OSOM Ultra Strep A 50 Test Kit
Sekisui Diagnostics, LLC Class I
Areta Strep A Swab Test Strip (25 tests kit)
EASY HEALTHCARE CORPORATION Class I
Group A Streptococcus Antigen Detection Kit (Immunochromatography)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Class I
McKesson
MCKESSON MEDICAL-SURGICAL INC. Class I
QuickVue
Quidel Corp. Class I
Preview
WONDFO USA CO., LTD. Class I
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Beckman Coulter, Inc. Class I
Rapid Response
BTNX Inc Class I
Detector Strep A
IMMUNOSTICS, INC. Class I
Areta Strep A Swab Test Strip (25 tests kit)
EASY HEALTHCARE CORPORATION Class I
OSOM Ultra Strep A 5 Test Kit
Sekisui Diagnostics, LLC Class I
Status Strep A Flip
PRINCETON BIOMEDITECH CORP. Class I
EY-20(TM) Reagent Tube
E-Y Laboratories, Inc.
Rapid Response
BTNX Inc Class I
BioSign® Strep A card
PRINCETON BIOMEDITECH CORP. Class I
Status Strep A Plus
PRINCETON BIOMEDITECH CORP. Class I
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Beckman Coulter, Inc. Class II
Henry Schein
HENRY SCHEIN, INC. Class I
Group A Streptococcus Antigen Detection Kit (Immunochromatography)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Class I
Poly stat
POLYMEDCO, INC. Class I
STREP A, MERIDIAN IMMUNO 50 Test Kit
Sekisui Diagnostics, LLC Class I
Preview
WONDFO USA CO., LTD. Class I
CARDINAL HEALTH
Cardinal Health 200, LLC Class I
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Beckman Coulter, Inc. Class II
QuickVue
Quidel Corp. Class I
OSOM Ultra Strep A 25 Test Kit
Sekisui Diagnostics, LLC Class I
BinaxNOW Strep A Card
Alere Scarborough, Inc. Class I
QuickVue
Quidel Corp. Class I
OSOM Strep A 50 Test Kit
Sekisui Diagnostics, LLC Class I
Poly stat
POLYMEDCO, INC. Class I
CARDINAL HEALTH
Cardinal Health 200, LLC Class I
Nano-Check TM Strep A Test
Nano-Ditech Corporation