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Direct Amplification Disc MOL1451

by DiaSorin Molecular LLC 2 variants

Direct Amplification Disc MOL1451 is a Class II device made by DiaSorin Molecular LLC, cleared under FDA 510(k) K102314 on 29 Oct 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 30816101025085), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K102314

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30816101025085 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102314 Date29 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102314 decided 29 Oct 2010 Active
  • FDA GUDID UDI-DI 30816101025085 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102314
  2. Listed FDA GUDID 30816101025085

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Direct Amplification Disc
Generic name
Microplate IVD
Model / Ref / Catalog
MOL1451
Primary DI / UDI-DI
30816101025085
510(k) Number
FDA product code
OOI
GMDN term
Microplate IVD
Device class
Class II
Regulation number
862.2570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microplate IVD

Cleared under the same submission (K102314)

and 6 more cleared under K102314

Other devices from DiaSorin Molecular LLC

See all devices from DiaSorin Molecular LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)