FDA.reportPublic FDA data

Alere™ i Instrument

Primary DI
00811877010838
Brand
Alere™ i Instrument
Company
Alere Scarborough, Inc.
Model
EQ00200XS
Device description
The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141520000ALERE I INFLUENZA A & BAlere Scarborough, Inc D/B/A Binax, Inc.2014-06-13OCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811877010838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811877010838008118770108388118770108380811877010838

GMDN Terms#

Term, Definition table
TermDefinition
Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (e.g., in real-time). The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Serial number
true

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