BinaxNOW™ Legionella Control Swab Pack

GUDID 10811877011054

Control Swabs to be used with the BinaxNOW™ Legionella Urinary Antigen Card.

Alere Scarborough, Inc.

Legionella pneumophila antigen IVD, control
Primary Device ID10811877011054
NIH Device Record Key27aeae37-cd5b-44d7-884b-9bc5f8ea8d1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBinaxNOW™ Legionella Control Swab Pack
Version Model Number852-010
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 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
GS110811877011054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJHLegionella, Spp., Elisa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-23
Device Publish Date2019-07-15

Devices Manufactured by Alere Scarborough, Inc.

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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

Trademark Results [BinaxNOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BINAXNOW
BINAXNOW
76505933 2861132 Live/Registered
ALERE SCARBOROUGH, INC.
2003-04-14

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