DiviTum®TKa

GUDID 07350095910030

DiviTumTKa is an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients. A TKa value of < 250 DuA is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. DiviTumTKa results should be used in conjunction with other clinical methods for monitoring breast cancer.

Biovica International AB

Thymidine kinase IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07350095910030
• NIH Device Record Key: 308d977c-accc-4a04-8efa-f81e1ae61817
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiviTum®TKa
• Version Model Number: 95010
• Company DUNS: 776734126
• Company Name: Biovica International AB
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com
• Phone: +1 (858) 230-6044
• Email: us@biovica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350095910030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202852

FDA Product Code

• QTE: Thymidine Kinase Activity

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: 2024-11-07
• Device Publish Date: 2023-01-22