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Bio-Stat YY60126

by Clark Laboratories, Inc.

Ref YY60126

Bio-Stat YY60126 is a device classified as IVD General (EU), Class II (US) made by Clark Laboratories, Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-05391516746588) and listed in FDA GUDID since 30 Dec 2019 (UDI-DI 05391516746588), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05391516746588 Basic UDI-DI 05391516746588UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516746588 UDI-DI Date30 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05391516746588 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 05391516746588 listed 30 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05391516746588
  2. Registered EUDAMED B-05391516746588

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Bio-Stat Syphilis EIA Test Kit EUDAMED
Bio-Stat GUDID
Generic name
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)
Device name
Bio-Stat Syphilis EIA (480 Tests)
Model / reference
YY60126
Primary DI / UDI-DI
05391516746588
Basic UDI-DI
B-05391516746588
FDA product code
LIP
EMDN code
W0105010302 Syphilis antibody assays total
GMDN term
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.3830
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices in this category

Other devices filed under SYPHILIS ANTIBODY ASSAYS TOTAL.

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)