Home GUDID 10811877010569 Alere NMP22 BladderChek Test
Primary DI 10811877010569
Brand Alere NMP22 BladderChek Test
Company Alere Scarborough, Inc.
Model D1200
Device description The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Published 2014-09-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MMW System, Test, Tumor Marker, Monitoring, Bladder NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MMW System, Test, Tumor Marker, Monitoring, Bladder Immunology 2 NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10811877010569 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10811877010569 10811877010569
GMDN Terms# Term, Definition table Term Definition Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of nuclear matrix protein 22 in 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 as a marker for urinary bladder cancer. It is not intended to be used for self-testing.
Regulatory Flags# DUNS number 154148498 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290019028000 Bladder EpiCheck Extraction Kit NUCLEIX LTD MMW 2023-10-13 07290019028208 Bladder EpiCheck Test Kit NUCLEIX LTD MMW 2023-10-13 00811877011538 NMP22 BladderChek Test Alere Scarborough, Inc. MMW 2022-08-08 00811877011538 NMP22 BladderChek Test Alere Scarborough, Inc. NAH 2022-08-08 00811877011552 NMP22 BladderChek Control Kit Alere Scarborough, Inc. MMW 2022-08-08 06009544019497 N/A SOUTHERN IMPLANTS (PTY) LTD NAH 2022-03-19 00859598007041 Contour Healer CONTOUR HEALER, LLC NAH 2018-09-07 00859598007119 Contour Healer CONTOUR HEALER, LLC NAH 2018-09-07 00859598007126 Contour Healer CONTOUR HEALER, LLC NAH 2018-09-07 10743816001393 Status BTA Card PRINCETON BIOMEDITECH CORPORATION MMW 2016-11-30 10743816001409 Status BTA Card PRINCETON BIOMEDITECH CORPORATION MMW 2016-11-30 00855574005001 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005261 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005278 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005285 BTA TRAK POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005292 BTA TRAK POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005353 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005629 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 00855574005636 BTA stat POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC MMW 2016-09-23 10811877010545 Alere NMP22 Test Alere Scarborough, Inc. NAH 2014-09-01 10811877010606 Alere NMP22 BladderChek Control Kit Alere Scarborough, Inc. MMW 2014-09-01 10811877010637 Alere NMP22® Urine Collection Kit Alere Scarborough, Inc. NAH 2014-09-01 10811877010774 Alere NMP22 BladderChek Test Alere Scarborough, Inc. NAH 2014-09-01 10811877010774 Alere NMP22 BladderChek Test Alere Scarborough, Inc. MMW 2014-09-01