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IsoPSA Controls P901

by Cleveland Diagnostics, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00860012266715 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: 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  • Withdrawn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
IsoPSA Controls
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Model / Ref / Catalog
P901
Primary DI / UDI-DI
00860012266715
PMA Number
FDA Product Code
QRF
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P200048)

Other devices from Cleveland Diagnostics, Inc.

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