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DiviTum®TKa 95010

by Biovica International AB GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350095910030 UDI-DIDate22 Jan 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
DiviTum®TKa
Generic Name
Thymidine kinase IVD, kit, enzyme immunoassay (EIA)
Model / Reference
95010
Primary DI / UDI-DI
07350095910030
510(k) Number
FDA Product Code
QTE
GMDN Term
Thymidine kinase IVD, kit, enzyme immunoassay (EIA)
Device Class
Class II
Regulation Number
866.6010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Thymidine kinase IVD, kit, enzyme immunoassay (EIA)

Other devices from Biovica International AB

  • DiviTum TKa

    Class II

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No