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Cue Sample Collection Kit C2238

by Cue Health Inc.

Cue Sample Collection Kit C2238 is a capillary blood collection kit IVD (FDA Class II; FDA product code PQD, Blood Specimen Collection Convenience Kit (Excludes Hiv)) made by Cue Health Inc., listed in FDA GUDID since 27 Feb 2023 (UDI-DI 00810040820649), 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 Number00810040820649 UDI-DI Date27 Feb 2023ListedStatusListed 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  • Withdrawn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
Cue Sample Collection Kit
Generic name
Capillary blood collection kit IVD
Model / reference
C2238
Primary DI / UDI-DI
00810040820649
FDA product code
PQD
GMDN term
Capillary blood collection kit IVD
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

Related devices

Category: Capillary blood collection kit IVD

Other devices from Cue Health Inc.

See all devices from Cue Health Inc. →

Properties

  • Single use
  • Over-the-counter
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)