FDA.reportPublic FDA data

Alere Reader BinaxNOW Tray Pack

Primary DI
10811877011016
Brand
Alere Reader BinaxNOW Tray Pack
Company
Alere Scarborough, Inc.
Model
LFR-004
Device description
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).
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162642000Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.2017-04-10PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877011016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701101610811877011016

GMDN Terms#

Term, Definition table
TermDefinition
Immunoassay reagent vehicle tray IVD, reusableA removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30