Skip to content

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 LDZ, Fixative, Alcohol Containing) made by CalibreScientific US, Inc., cleared under FDA 510(k) K881698 on 13 May 1988 and listed in FDA GUDID since 11 Aug 2022 (UDI-DI 00816085022444), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K881698

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816085022444 UDI-DI Date11 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK881698 Date13 May 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K881698 decided 13 May 1988 Active
  • FDA GUDID UDI-DI 00816085022444 listed 11 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K881698
  2. Listed FDA GUDID 00816085022444

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alpha-Tec Systems
Generic name
Faecal specimen collection kit IVD, home-use
Model / reference
0
Primary DI / UDI-DI
00816085022444
510(k) Number
FDA product code
LDZ
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

Cleared under the same submission (K881698)

and 8 more cleared under K881698

Similar devices

Other devices filed under FDA product code LDZ (Fixative, Alcohol Containing).

Other devices from CalibreScientific US, Inc.

See all devices from CalibreScientific US, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)