Alere Reader BinaxNOW Tray Pack

GUDID 10811877011016

A tray insert to be used with the Alere Reader to ensure correct placement of the immunoassay reagent vehicle (e.g., test strip, cassette, or card).

Alere Scarborough, Inc.

Immunoassay reagent vehicle tray IVD, reusable
Primary Device ID10811877011016
NIH Device Record Key874dec3b-3ed6-4044-a768-5a5b5e7b81f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlere Reader BinaxNOW Tray Pack
Version Model NumberLFR-004
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877011016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2017-12-28

Devices Manufactured by Alere Scarborough, Inc.

00811877012030 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012047 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012054 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012061 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012078 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012085 - BinaxNOW COVID-19/Flu A&B Combo Self Test2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012092 - BinaxNOW COVID-19/Flu A&B 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
00811877012108 - BinaxNOW COVID-19/Flu A&B Controls2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

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