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Parsortix® PC1 system ICT-IVD-01-010.B2-US

by Angle PLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number05056364200117 UDI-DI Date1 Apr 2024ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Parsortix® PC1 system
Generic Name
Circulating tumour cell separation system control IVD
Model / Reference
ICT-IVD-01-010.B2-US
Primary DI / UDI-DI
05056364200117
De Novo Number
FDA Product Code
QSA
GMDN Term
Circulating tumour cell separation system control IVD
Device Class
Class II
Regulation Number
866.6110
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Circulating tumour cell separation system control IVD

Properties

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

Other properties (10)

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