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Accula Dock D2000

by Mesa Biotech, Inc.

Accula Dock D2000 is a device classified as Not classified made by Mesa Biotech, Inc., listed in FDA GUDID since 13 Apr 2020 (UDI-DI B540D20000), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB540D20000 UDI-DI Date13 Apr 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Accula Dock
Generic name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Model / Ref / Catalog
D2000
Primary DI / UDI-DI
B540D20000
FDA product code
QJR, OZE, OCC
GMDN term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Device class
N
Regulation number
866.3980
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code OZE.

Other devices from Mesa Biotech, Inc.

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)