Skip to content

FastPack® Control Kit Multi-Analyte Controls

by Qualigen Inc.

Ref 25000065

FastPack® Control Kit Multi-Analyte Controls (25000056) is a device classified as IVD General (EU), Class I (US) made by Qualigen Inc., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI B-00816467020136), cleared under FDA 510(k) K123725 on 8 Mar 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00816467020136), active as of 22 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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K123725

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00816467020136 Basic UDI-DI 00816467020136UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816467020136 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123725 Date8 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816467020136 registered 14 Sep 2026 Active
  • FDA 510(k) K123725 decided 8 Mar 2013 Active
  • FDA GUDID UDI-DI 00816467020136 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) K123725
  2. Listed FDA GUDID 00816467020136
  3. Registered EUDAMED B-00816467020136

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  • Withdrawn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
FastPack® Control Kit
Generic name
Multiple clinical chemistry enzyme IVD, control
Device name
FastPack Control Kit International
Model / Ref / Catalog
25000065 EUDAMED
Multi-Analyte Controls GUDID
25000056 GUDID
Primary DI / UDI-DI
00816467020136
Basic UDI-DI
B-00816467020136
510(k) Number
FDA product code
JJY
EMDN code
W0101050199 Multicomponent controls (cc) - other
GMDN term
Multiple clinical chemistry enzyme IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
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
25000065
GUDID
Multi-Analyte Controls
Device classEUDAMED
Class IVD General
GUDID
Class I

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

Related devices

Category: Multiple clinical chemistry enzyme IVD, control

Similar devices in this category

Other devices filed under MULTICOMPONENT CONTROLS (CC) - OTHER.

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)