Skip to content

Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack MOL4460

by DiaSorin Molecular LLC

Ref MOL4460

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081610102MOL4460TT Basic UDI-DI 20816101027365UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20816101027365 UDI-DI Date14 Jan 2026ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Simplexa™ COVID-19 / Flu A/B & RSV Positive Control Pack EUDAMED
Simplexa COVID-19 / Flu A/B & RSV Positive Control Pack GUDID
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, control
Model / Ref / Catalog
MOL4460
Primary DI / UDI-DI
20816101027365
Basic UDI-DI
081610102MOL4460TT
Direct Marketing DI
20816101027365
FDA Product Code
QOF, OOI
EMDN Code
W0105080808 All infectious diseases controls - nat
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, control
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.3981, 862.2570
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Other devices from DiaSorin Molecular LLC

See all devices from DiaSorin Molecular LLC →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

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