FDA.reportPublic FDA data

BTA stat

Primary DI
00855574005001
Brand
BTA stat
Company
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Model
661510
Device description
BTA stat Test - 10 Test kit - Hitado Labeled
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K974845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974845000BTA STAT TEST PRESCRIPTION HOME USEBard Diagnostic Sciences,Inc.1998-12-08MMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855574005001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855574005001008555740050018555740050010855574005001

GMDN Terms#

Term, Definition table
TermDefinition
Bladder tumour associated antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of bladder tumour associated antigen in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078413594
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
00816917027845OC-AutoOCPUIO-YNHM2026-08-07
00816917027852OC-AutoOCPU-THSJI2026-08-07
00816917027869OC-AutoOCPUIO-HVMA2026-08-07
00816917027876OC-AutoOCPUIO-IUHPL2026-08-07
00816917027883OC-AutoOCPUIO-VA1 23341022026-08-07
00816917027890OC-AutoOCPUIO-VA1 23343372026-08-07
00816917027906OC-AutoOCPUIO-LGH2026-08-07
00816917027913OC-AutoOCPUIO-UMICH2026-08-07
00816917027920OC-AutoOCPUIO-PHE2026-08-07
00816917027937OC-AutoOCPUIO-HNL2026-08-07
00855574005285BTA TRAK6621502016-09-23
00855574005292BTA TRAK6621602016-09-23
00816917027838OC-AutoOCPUIO-DCRV2026-04-03
00816917027821OC-Light SFBPUS-MCWI2026-03-25
00816917027814OC-AutoOCPUIO-STF2026-03-18
00816917027784OC-AutoOCPUIO-GHS12026-03-13
00816917027791OC-AutoOCPUIO-GHS22026-03-13
00816917027807OC-AutoOCPUIO-DHW2026-03-13
00816917027760OC-AutoOCPUIO-ANMC2026-02-27
00816917027777OC-AutoOCPUIO-VA1 9158942026-02-27

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
00811877011552NMP22 BladderChek Control KitAlere Scarborough, Inc.MMW2022-08-08
10743816001393Status BTA CardPRINCETON BIOMEDITECH CORPORATIONMMW2016-11-30
10743816001409Status BTA CardPRINCETON BIOMEDITECH CORPORATIONMMW2016-11-30
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