ID NOW™ Instrument

GUDID 00811877010616

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.

Alere Scarborough, Inc.

Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory Isothermal nucleic acid amplification analyser IVD, laboratory
Primary Device ID00811877010616
NIH Device Record Keyda6e9cb5-fec5-4f37-a74a-732f4e2acdbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameID NOW™ Instrument
Version Model NumberEQ00200XS
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 Batchfalse
Serial Numbertrue
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
GS100811877010616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-29
Device Publish Date2018-10-29

On-Brand Devices [ID NOW™ Instrument]

00811877010616The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for th
00811877010593The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for th

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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