BinaxNOW Strep A Card

GUDID 10811877010927

A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat swab specimens.

Alere Scarborough, Inc.

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Primary Device ID10811877010927
NIH Device Record Key3fb39248-a19c-43b1-8216-492b9d2630a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBinaxNOW Strep A Card
Version Model Number735-025
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
GS110811877010927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GTZAntisera, All Groups, Streptococcus Spp.

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 Strep A Card]

10811877010927A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat
10811877010453A rapid test for the qualitative detection of Streptococcus pyogenes Group A antigen from throat

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