FDA.reportPublic FDA data

BTA TRAK

Primary DI
00855574005292
Brand
BTA TRAK
Company
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Model
662160
Device description
BTA TRAK - Internationally Labeled
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855574005292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855574005292008555740052928555740052920855574005292

GMDN Terms#

Term, Definition table
TermDefinition
Bladder tumour associated antigen 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 bladder tumour associated antigen in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
078413594
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00816917027753OC-AutoOCPUIO-GSJH2026-02-13

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
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
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