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Lysercell Wdf II CY754019

by Sysmex Corp.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00664369000899 UDI-DI Date24 Apr 2026ListedStatusListed 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  • Withdrawn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
Lysercell Wdf II
Generic Name
Blood cell lysis reagent IVD
Model / Ref / Catalog
CY754019, ZA900014
Primary DI / UDI-DI
00664369000899
FDA Product Code
GGK
GMDN Term
Blood cell lysis reagent IVD
Device Class
Class I
Regulation Number
864.8540
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Liter

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No