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Simplexa COVID-19 / Flu A/B & RSV Direct MOL4450

by DiaSorin Molecular LLC

Ref MOL4450

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 Number081610102MOL4450TQ Basic UDI-DI 20816101027358UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20816101027358 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  • Withdrawn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 Direct EUDAMED
Simplexa COVID-19 / Flu A/B & RSV Direct GUDID
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Model / Ref / Catalog
MOL4450
Primary DI / UDI-DI
20816101027358
Basic UDI-DI
081610102MOL4450TQ
Direct Marketing DI
20816101027358
FDA Product Code
QOF, OOI
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: 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