FDA.reportPublic FDA data

Alere NMP22 Test

Primary DI
10811877010545
Brand
Alere NMP22 Test
Company
Alere Scarborough, Inc.
Model
D1100E
Device description
For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
Published
2014-09-01
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
NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAHSystem, Test, Tumor Marker, For Detection Of Bladder CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P940035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P940035000NMP22 BladderChek TestAbbott Diagnostics Scarborough, Inc.1996-07-02NAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701054510811877010545

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nuclear matrix protein 22 in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
00811877011538NMP22 BladderChek TestAlere Scarborough, Inc.NAH2022-08-08
06009544019497N/ASOUTHERN IMPLANTS (PTY) LTDNAH2022-03-19
00859598007041Contour HealerCONTOUR HEALER, LLCNAH2018-09-07
00859598007119Contour HealerCONTOUR HEALER, LLCNAH2018-09-07
00859598007126Contour HealerCONTOUR HEALER, LLCNAH2018-09-07
10811877010637Alere NMP22® Urine Collection Kit Alere Scarborough, Inc.NAH2014-09-01
10811877010569Alere NMP22 BladderChek TestAlere Scarborough, Inc.NAH2014-09-01
10811877010774Alere NMP22 BladderChek TestAlere Scarborough, Inc.NAH2014-09-01