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Simplexa™ Spectral Calibration Panel SC1100

by DiaSorin Molecular LLC

Ref SC1100

Simplexa™ Spectral Calibration Panel SC1100 is a Class A device made by DiaSorin Molecular LLC, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 081610102SC1100HU), cleared under FDA 510(k) K102314 on 29 Oct 2010 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 20816101025101), active as of 7 Nov 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102314

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081610102SC1100HU Basic UDI-DI 20816101025101UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20816101025101 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK102314 Date29 Oct 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081610102SC1100HU registered 29 Oct 2026 Active
  • FDA 510(k) K102314 decided 29 Oct 2010 Active
  • FDA GUDID UDI-DI 20816101025101 listed 14 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K102314
  2. Listed FDA GUDID 20816101025101
  3. Registered EUDAMED 081610102SC1100HU

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Simplexa™ Spectral Calibration Panel
Generic name
Optical laboratory instrument performance standard calibrator/control IVD, reusable
Model / Ref / Catalog
SC1100
Primary DI / UDI-DI
20816101025101
Basic UDI-DI
081610102SC1100HU
Direct marketing DI
20816101025101
510(k) Number
EMDN code
W02050185 Nucleic acid testing instruments except micro-arrays - consumables
GMDN term
Optical laboratory instrument performance standard calibrator/control IVD, reusable
Device class
Class A
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Optical laboratory instrument performance standard calibrator/control IVD, reusable

Cleared under the same submission (K102314)

and 6 more cleared under K102314

Similar devices in this category

Other devices filed under NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES.

Other devices from DiaSorin Molecular LLC

See all devices from DiaSorin Molecular LLC →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)