Bladder EpiCheck Test Kit

Primary DI
07290019028208
Brand
Bladder EpiCheck Test Kit
Company
NUCLEIX LTD
Model
02
Catalog number
NX899090-02US
Published
2023-10-13
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
K203245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203245000Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03CNucleix , Ltd.2023-05-04MMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019028208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019028208072900190282087290019028208

GMDN Terms#

Term, Definition table
TermDefinition
Methylated DNA IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials (e.g., software) intended to be used for the qualitative and/or quantitative detection of methylated DNA in a clinical specimen. Methylated DNA and DNA methylation patterns in specific genes or genomic regions are typically associated with the development of cancer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius-15 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532498271
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
07290019028000Bladder EpiCheck Extraction Kit01NX899090-01-US2023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019028000Bladder EpiCheck Extraction KitNUCLEIX LTDMMW2023-10-13
00811877011538NMP22 BladderChek TestAlere Scarborough, Inc.MMW2022-08-08
00811877011552NMP22 BladderChek Control KitAlere 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