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Alpha-Tec Systems 0

by CalibreScientific US, Inc. 154 variants

Part of a family of 57 devices: see the family page

Ref 0003928Model Digestion and Decontamination Reagents

Alpha-Tec Systems 0 (0003928) is a device classified as Class A in the EU and Class I in the US made by CalibreScientific US, Inc., registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 081608502DIGESTDECONFT), cleared under FDA 510(k) K881042 on 30 Mar 1988 and listed in FDA GUDID since 10 Aug 2022 (UDI-DI 00816085021867), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K881042

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081608502DIGESTDECONFT Basic UDI-DI 00816085021867UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816085021867 UDI-DI Date10 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK881042 Date30 Mar 1988DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081608502DIGESTDECONFT registered 4 Aug 2026 Active
  • FDA 510(k) K881042 decided 30 Mar 1988 Active
  • FDA GUDID UDI-DI 00816085021867 listed 10 Aug 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K881042
  2. Listed FDA GUDID 00816085021867
  3. Registered EUDAMED 081608502DIGESTDECONFT

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
UNITARY™ Specimen Tubes EUDAMED
Alpha-Tec Systems GUDID
Generic name
Sputum specimen liquefaction/decontamination kit IVD
Model / Ref / Catalog
Digestion and Decontamination Reagents, 0003928, 0
Primary DI / UDI-DI
00816085021867
Basic UDI-DI
081608502DIGESTDECONFT
510(k) Number
FDA product code
JTS
EMDN code
W010499 Microbiology tests - other
GMDN term
Sputum specimen liquefaction/decontamination kit IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.1850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Digestion and Decontamination Reagents
0003928
GUDID
0
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Sputum specimen liquefaction/decontamination kit IVD

Cleared under the same submission (K881042)

and 4 more cleared under K881042

Similar devices in this category

Other devices filed under MICROBIOLOGY TESTS - OTHER.

Other devices from CalibreScientific US, Inc.

See all devices from CalibreScientific US, Inc. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)