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Alpha-Tec Systems 0

by CalibreScientific US, Inc. 112 variants

Alpha-Tec Systems 0 is a faecal specimen collection kit IVD (FDA Class I; FDA product code IGB, Solution, Formalin-Sodium Acetate) made by CalibreScientific US, Inc., listed in FDA GUDID since 10 Aug 2022 (UDI-DI 00816085022666), 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 Number00816085022666 UDI-DI Date10 Aug 2022ListedStatusListed 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  • Withdrawn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
Alpha-Tec Systems
Generic name
Faecal specimen collection kit IVD, home-use
Model / reference
0
Primary DI / UDI-DI
00816085022666
FDA product code
IGB
GMDN term
Faecal specimen collection kit IVD, home-use
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal specimen collection kit IVD, home-use

Other devices from CalibreScientific US, Inc.

See all devices from CalibreScientific US, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)