FDA.reportPublic FDA data

BinaxNOW® Malaria Positive Control Kit

Primary DI
10811877010712
Brand
BinaxNOW® Malaria Positive Control Kit
Company
Alere Scarborough, Inc.
Model
665-010
Device description
The BinaxNOW® Malaria Positive Control.
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
MJZKit, Direct Antigen, Positive Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJZKit, Direct Antigen, Positive ControlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083744000BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010Binax, Inc.2009-09-01MJZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701071210811877010712

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Plasmodium species antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
00816862027303WELLlife™WONDFO USA CO., LTD.MJZ2026-06-01
30014613340768QuickVue™WONDFO USA CO., LTD.MJZ2025-10-31
08809115900401QuickFinder™ COVID-19/Flu Antigen Pro Control Swab KitOSANG HEALTHCARE Co., Ltd.MJZ2025-03-12
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJZ2024-03-15
10845357043754Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.MJZ2022-02-16