Status BTA Card BSP-307-10-00

GUDID 10743816001409

Status BTA (CLIA Waived); 10 Test Kit

PRINCETON BIOMEDITECH CORPORATION

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

• Primary Device ID: 10743816001409
• NIH Device Record Key: 33136fc1-e249-4e8d-b76a-76845797918a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status BTA Card
• Version Model Number: BSP-307-10-00
• Catalog Number: BSP-307-10-00
• 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: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• Email: info@lifesignmed.com
• Phone: 8005262125
• 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	10743816001409 [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