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Cellsheath 05404811

by Sysmex Corporation

Cellsheath 05404811 is a Class I device made by Sysmex Corporation, listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04987562406005), registry data as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987562406005 UDI-DI Date30 Nov 2022ListedStatusListed 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  • Withdrawn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
Cellsheath
Generic name
Buffered sample diluent IVD
Model / reference
05404811
Primary DI / UDI-DI
04987562406005
FDA product code
GIF
GMDN term
Buffered sample diluent IVD
Device class
Class I
Regulation number
864.8200
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 10 Liter

Related devices

Category: Buffered sample diluent IVD

Similar devices in this category

Other devices filed under Buffered sample diluent IVD.

Other devices from Sysmex Corporation

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)