FDA.reportPublic FDA data

NMP22 BladderChek Control Kit

Primary DI
00811877011552
Brand
NMP22 BladderChek Control Kit
Company
Alere Scarborough, Inc.
Model
D1250
Device description
NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the NMP22 BladderChek Test.
Published
2022-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MMWSystem, Test, Tumor Marker, Monitoring, Bladder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMWSystem, Test, Tumor Marker, Monitoring, BladderImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021231000NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMatritech, Inc.2002-07-30MMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811877011552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811877011552008118770115528118770115520811877011552

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear matrix protein 22 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 nuclear matrix protein 22 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
07290019028000Bladder EpiCheck Extraction KitNUCLEIX LTDMMW2023-10-13
07290019028208Bladder EpiCheck Test KitNUCLEIX LTDMMW2023-10-13
00811877011538NMP22 BladderChek TestAlere Scarborough, Inc.MMW2022-08-08
10743816001393Status BTA CardPRINCETON BIOMEDITECH CORPORATIONMMW2016-11-30
10743816001409Status BTA CardPRINCETON BIOMEDITECH CORPORATIONMMW2016-11-30
00855574005001BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005261BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005278BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005285BTA TRAKPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005292BTA TRAKPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005353BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005629BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
00855574005636BTA statPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMMW2016-09-23
10811877010606Alere NMP22 BladderChek Control Kit Alere Scarborough, Inc.MMW2014-09-01
10811877010569Alere NMP22 BladderChek TestAlere Scarborough, Inc.MMW2014-09-01
10811877010774Alere NMP22 BladderChek TestAlere Scarborough, Inc.MMW2014-09-01