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Cue Sample Collection Kit C2241

by Cue Health Inc.

Cue Sample Collection Kit C2241 is a faecal specimen collection kit IVD (FDA Class I; FDA product code NNK, Container, Specimen Mailer And Storage, Non-Sterile) made by Cue Health Inc., listed in FDA GUDID since 27 Feb 2023 (UDI-DI 00810040820618), 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 Number00810040820618 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  • Withdrawn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
Faecal specimen collection kit IVD, home-use
Model / reference
C2241
Primary DI / UDI-DI
00810040820618
FDA product code
NNK
GMDN term
Faecal specimen collection kit IVD, home-use
Device class
Class I
Regulation number
864.3250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal specimen collection kit IVD, home-use

Similar devices

Other devices filed under FDA product code NNK (Container, Specimen Mailer And Storage, Non-Sterile).

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)