Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

FDA product code GQG · 32 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.3480
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-05-20 – 2026-01-30

GQG 2026-01-30

Clungene RSV Antigen Rapid Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K253318

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GQG 2024-07-30

Nano-Check™ RSV Test

Applicant Nano-Ditech Corporation

K number K240280

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GQG 2017-02-22

Sofia RSV FIA on Sofia 2 analyzer

Applicant Quidel Corporation

K number K162911

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GQG 2013-11-15

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV

Applicant Becton, Dickinson & CO

K number K133140

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GQG 2013-11-07

BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

Applicant Becton, Dickinson and Company

K number K132456

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GQG 2013-08-13

SOFIA(R) RSV FIA

Applicant Quidel Corp.

K number K130398

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GQG 2012-09-18

BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV

Applicant Becton, Dickinson and Company

K number K121633

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GQG 2010-09-24

QUICKVUE RSV 10

Applicant Quidel Corp.

K number K101918

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GQG 2010-07-09

BD DIRECTIGEN EZ RSV

Applicant Becton, Dickinson & CO

K number K101514

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GQG 2009-07-24

RAMP RSV ASSAY

Applicant Response Biomedical Corp.

K number K091235

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GQG 2007-04-23

QUICK VUE RSV TEST, MODELS 20193, 20199

Applicant Quidel Corp.

K number K070747

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GQG 2004-08-13

IMMUNOCARD STAT! RSV MODEL #750630

Applicant Meridian Bioscience, Inc.

K number K041445

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GQG 2003-10-21

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

Applicant Binax, Inc.

K number K032166

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GQG 2003-01-29

SAS RSV TEST

Applicant Sa Scientific, Inc.

K number K022845

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GQG 2003-01-14

RSV OIA

Applicant Thermo Biostar, Inc.

K number K023779

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GQG 2002-12-10

BD DIRECTIGEN EZ RSV KIT

Applicant Becton, Dickinson & CO

K number K022133

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GQG 2002-11-20

QUICKLAB RSV

Applicant Integrated Biotechnology Corp.

K number K021789

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GQG 2002-09-13

BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

Applicant Binax, Inc.

K number K021687

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GQG 1997-03-18

RSV ANTIGEN CONTROL SLIDES

Applicant Viral Antigens, Inc.

K number K964870

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GQG 1990-02-26

VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY

Applicant Vitek Systems, Inc.

K number K896097

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GQG 1989-01-13

FITC MURINE MONOCLONAL ANTI-RSV IGG

Applicant Whittaker Bioproducts, Inc.

K number K884516

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GQG 1988-10-31

DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K882629

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GQG 1988-06-22

ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL

Applicant Abbott Laboratories

K number K882277

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GQG 1988-05-06

ABBOTT TESTPACK RSV

Applicant Abbott Laboratories

K number K874127

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GQG 1986-09-29

PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS

Applicant Kallestad Laboratories, Inc.

K number K862743

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GQG 1986-09-16

ABBOTT RSV EIA

Applicant Abbott Laboratories

K number K862429

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GQG 1986-01-03

IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST

Applicant Boots-Celltech Diagnostics, Inc.

K number K854081

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GQG 1985-12-04

RESPIRATORY SYNCYTIAL VIRUS ID REAGENT

Applicant Viromed Laboratories, Inc.

K number K853695

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GQG 1985-09-26

RESPIRATORY SYNCYTIAL VIRUS

Applicant Institute Virion , Ltd.

K number K843673

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GQG 1980-12-31

RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &

Applicant Orion Diagnostica, Inc.

K number K802936

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GQG 1977-05-20

RESP. SYNCYTIAL-FA LABELLED PRESERUM

Applicant Flow Laboratories, Inc.

K number K770808

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GQG 1977-05-20

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)

Applicant Flow Laboratories, Inc.

K number K770804

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