ID NOW™ COVID-19 Control Swab Kit

GUDID 10811877011276

Control Swabs intended for use only with the ID NOW™ COVID-19 product. Refer to the ID NOW COVID-19 Product Insert for instructions for use. Contents: 12 Positive Control Swabs, 12 Negative Control Swabs

Alere Scarborough, Inc.

SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control SARS-CoV-2 nucleic acid IVD, control
Primary Device ID10811877011276
NIH Device Record Keyaf653868-e134-402a-b296-eb77964f4686
Commercial Distribution StatusIn Commercial Distribution
Brand NameID NOW™ COVID-19 Control Swab Kit
Version Model Number190-080
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
GS110811877011276 [Primary]

FDA Product Code

QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-20
Device Publish Date2020-03-30

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00811877011477 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011507 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011798 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
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Trademark Results [ID NOW]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ID NOW
ID NOW
88037536 not registered Live/Pending
Alere Scarborough, Inc.
2018-07-13
ID NOW
ID NOW
88037535 not registered Live/Pending
Alere Scarborough, Inc.
2018-07-13
ID NOW
ID NOW
88037533 not registered Live/Pending
Alere Scarborough, Inc.
2018-07-13

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