BTA stat

GUDID 00855574005261

BTA stat Test - 10 Test kit - Internationally Labeled

POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC

Bladder tumour associated antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00855574005261
• NIH Device Record Key: 4e2508d0-ebb4-44fe-8b95-eb4c45f7538e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTA stat
• Version Model Number: 661010
• 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: false
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855574005261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974845

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [BTA stat]

• 00855574005636: BTA stat Test - 30 Test kit - USA Labeled
• 00855574005629: BTA stat Test - 10 Test kit - US Labeled
• 00855574005353: BTA stat - Controls - US Labeled 15 Deteriminations
• 00855574005278: BTA stat Test - 5 Test kit - Hitado Labeled
• 00855574005261: BTA stat Test - 10 Test kit - Internationally Labeled
• 00855574005001: BTA stat Test - 10 Test kit - Hitado Labeled