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Calibrator Kit - Testosterone Testo Cal

by Qualigen Inc.

Ref 25000014

Calibrator Kit - Testosterone Testo Cal (25000014) is a device classified as IVD General (EU), Class II (US) made by Qualigen Inc., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI B-00816467020044), cleared under FDA 510(k) K022533 on 30 Sep 2002 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816467020044), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K022533

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00816467020044 Basic UDI-DI 00816467020044UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816467020044 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK022533 Date30 Sep 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816467020044 registered 14 Sep 2026 Active
  • FDA 510(k) K022533 decided 30 Sep 2002 Active
  • FDA GUDID UDI-DI 00816467020044 listed 16 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K022533
  2. Listed FDA GUDID 00816467020044
  3. Registered EUDAMED B-00816467020044

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Calibrator Kit - Testosterone
Generic name
Total testosterone IVD, calibrator
Device name
FastPack Testo Calibrator
Model / Ref / Catalog
25000014, Testo Cal
Primary DI / UDI-DI
00816467020044
Basic UDI-DI
B-00816467020044
510(k) Number
FDA product code
JIT
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Total testosterone IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
25000014
GUDID
Testo Cal
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Total testosterone IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

Other devices from Qualigen Inc.

See all devices from Qualigen Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)