Status BTA Card BSP-307-25-00

GUDID 10743816001393

Status BTA (CLIA Waived); 25 Test Kit

PRINCETON BIOMEDITECH CORPORATION

Bladder tumour associated antigen IVD, kit, rapid ICT, clinical Bladder tumour associated antigen IVD, kit, rapid ICT, clinical Bladder tumour associated antigen IVD, kit, rapid ICT, clinical Bladder tumour associated antigen IVD, kit, rapid ICT, clinical Bladder tumour associated antigen IVD, kit, rapid ICT, clinical Bladder tumour associated antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 10743816001393
• NIH Device Record Key: 5dc79c14-1087-401f-a85c-925eb86038bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status BTA Card
• Version Model Number: BSP-307-25-00
• Catalog Number: BSP-307-25-00
• Company DUNS: 362917692
• Company Name: PRINCETON BIOMEDITECH CORPORATION
• 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

Customer Support Contacts

• Phone: 800-526-2125
• Email: info@lifesignmed.com
• Phone: 800-526-2125
• Email: info@lifesignmed.com
• Phone: 800-526-2125
• Email: info@lifesignmed.com
• Phone: 800-526-2125
• Email: info@lifesignmed.com
• Phone: 800-526-2125
• Email: info@lifesignmed.com
• Phone: 800-526-2125
• Email: info@lifesignmed.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10743816001393 [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: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-11-30

On-Brand Devices [Status BTA Card]

• 10743816001409: Status BTA (CLIA Waived); 10 Test Kit
• 10743816001393: Status BTA (CLIA Waived); 25 Test Kit