Skip to content

TECHNOZYM ADAMTS13 Activity ELISA

by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

Ref 5450701

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09120036862456 UDI-DI Date9 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDD EUDAMED NumberB-09120036862456 Basic UDI-DI 09120036862456UDI-DIDate20 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Technozym ADAMTS13 Activity
Generic Name
ADAMTS13 activity IVD, kit, enzyme immunoassay (EIA)
Device Name
TECHNOZYM ADAMTS13 Activity ELISA
Model / Ref / Catalog
5450701 EUDAMED
5450701-US GUDID
Primary DI / UDI-DI
09120036862456
Basic UDI-DI
B-09120036862456
De Novo Number
FDA Product Code
SAC
EMDN Code
W0103020399 Special coagulation tests - other
GMDN Term
ADAMTS13 activity IVD, kit, enzyme immunoassay (EIA)
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
864.7297
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5450701
GUDID
5450701-US
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

EUDAMED SRN
AT-MF-000024115

Other devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

See all devices from Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No