BinaxNOW RSV

GUDID 10811877011191

A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens.

Alere Scarborough, Inc.

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Primary Device ID10811877011191
NIH Device Record Keye836b536-faa7-4768-991a-067738b42c44
Commercial Distribution StatusIn Commercial Distribution
Brand NameBinaxNOW RSV
Version Model Number430-122
Company DUNS154148498
Company NameAlere Scarborough, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877011191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-24
Device Publish Date2020-09-16

On-Brand Devices [BinaxNOW RSV]

10811877011191A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an
10811877011184A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an
10811877011177A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an
10811877011160A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash an

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