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Caresphere Workflow Solution 1.X

by Sysmex America, Inc.

Caresphere Workflow Solution 1.X is a Class I device made by Sysmex America, Inc., listed in FDA GUDID since 7 Dec 2022 (UDI-DI 00664369000851), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00664369000851 UDI-DI Date7 Dec 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  • Withdrawn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
Caresphere Workflow Solution
Generic name
Clinical laboratory information system application software
Model / reference
1.X
Primary DI / UDI-DI
00664369000851
FDA product code
JQP
GMDN term
Clinical laboratory information system application software
Device class
Class I
Regulation number
862.2100
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JQP (Calculator/Data Processing Module, For Clinical Use).

Other devices from Sysmex America, Inc.

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Properties

  • Prescription use
  • Premarket exempt
Other properties (13, all answered No)