Skip to content

Technozym ADAMTS13 Activity

by Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM

De Novo DEN230024

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN230024 Date28 Feb 2024DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
SAC
Device Class
Class II
Regulation
21 CFR Part 864.7297
Advisory Committee
Hematology
FDA Decision
DENG De Novo granted