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Research and Diagnostic Systems PIX002

by Research and Diagnostic Systems, Inc.

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 Number00815762020490 UDI-DI Date1 Dec 2025ListedStatusListed 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  • Withdrawn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
Research and Diagnostic Systems
Generic name
Full blood count IVD, control
Model / reference
PIX002
Primary DI / UDI-DI
00815762020490
FDA product code
JCN
GMDN term
Full blood count IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution

Other devices from Research and Diagnostic Systems, Inc.

See all devices from Research and Diagnostic Systems, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Manufacturing date: No