FDA UDI
In Commercial Distribution
🇺🇸 United States
DiviTum®TKa
DI: 07350095910030
·
Model: 95010
·
Biovica International AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DiviTum®TKa
- Primary DI
- 07350095910030
- Version / Model
- 95010
- Company Name
- Biovica International AB
- Labeler DUNS
- 776734126
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-22
- Public Version
- 1
- Public Version Date
- 2023-01-30
- Public Version Status
- New
- Public Device Record Key
- 308d977c-accc-4a04-8efa-f81e1ae61817
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QTE | Thymidine Kinase Activity | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53173 | Thymidine kinase IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of thymidine kinase in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350095910030 | GS1 |
Customer Contacts
- Phone
- +1 (858) 230-6044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202852 | 000 |