Primary Device ID | 00855574005292 |
NIH Device Record Key | 8d659496-7361-4736-8e4e-4937812f8831 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BTA TRAK |
Version Model Number | 662160 |
Company DUNS | 078413594 |
Company Name | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855574005292 [Primary] |
MMW | System, Test, Tumor Marker, Monitoring, Bladder |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-23 |
00855574005292 | BTA TRAK - Internationally Labeled |
00855574005285 | BTA TRAK - USA Labeled |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BTA TRAK 76057645 2546239 Live/Registered |
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC 2000-05-26 |
![]() BTA TRAK 74732557 not registered Dead/Abandoned |
Bard Diagnostic Sciences, Inc. 1995-09-18 |