FDA.reportPublic FDA data

BinaxNOW® G6PD

Primary DI
10811877010705
Brand
BinaxNOW® G6PD
Company
Alere Scarborough, Inc.
Model
780-000
Device description
For the qualitative detection of G6PD enzyme activity in blood.
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), ScreeningHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701070510811877010705

GMDN Terms#

Term, Definition table
TermDefinition
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) activity in red cells from a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00819704020333FINDERBaebies, Inc.JBF2025-01-31
00819704020340FINDERBaebies, Inc.JBF2025-01-31
00819704020364FINDERBaebies, Inc.JBF2025-01-31
00811727014139Pointe G6PD ReagentHORIBA INSTRUMENTS INCORPORATEDJBF2021-01-30
00811727015679Pointe G6PD ControlsHORIBA INSTRUMENTS INCORPORATEDJBF2021-01-30