BTA TRAK

GUDID 00855574005285

BTA TRAK - USA Labeled

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Bladder tumour associated antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00855574005285
• NIH Device Record Key: 87cd8d26-c1cc-42e0-83d5-04751e5a961c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTA TRAK
• Version Model Number: 662150
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855574005285 [Primary]

FDA Product Code

• MMW: System, Test, Tumor Marker, Monitoring, Bladder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [BTA TRAK]

• 00855574005292: BTA TRAK - Internationally Labeled
• 00855574005285: BTA TRAK - USA Labeled