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Cell-Dyn 03H40-01

by Abbott Laboratories

Cell-Dyn 03H40-01 (03H4001) is a Class I device made by Abbott Laboratories, listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740005009), 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 Number00380740005009 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Cell-Dyn
Generic name
Reticulocyte count IVD, kit, cell count
Model / Ref / Catalog
03H40-01, 03H4001
Primary DI / UDI-DI
00380740005009
FDA product code
GJH
GMDN term
Reticulocyte count IVD, kit, cell count
Device class
Class I
Regulation number
864.1850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reticulocyte count IVD, kit, cell count

Other devices from Abbott Laboratories

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Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)