FDA.reportPublic FDA data

Alere NMP22® Urine Collection Kit

Primary DI
10811877010637
Brand
Alere NMP22® Urine Collection Kit
Company
Alere Scarborough, Inc.
Model
D2100E
Device description
The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere NMP22® (ELISA)Test Kit .
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
10811877010637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701063710811877010637

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear matrix protein 22 IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
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
10811877010545Alere NMP22 TestAlere Scarborough, Inc.NAH2014-09-01
10811877010569Alere NMP22 BladderChek TestAlere Scarborough, Inc.NAH2014-09-01
10811877010774Alere NMP22 BladderChek TestAlere Scarborough, Inc.NAH2014-09-01