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F.S. Test 00857

by Diagnostica Stago, Inc. EUDAMEDGUDID

Active European Union

Ref 00857

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-03607450008579 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03607450008579 UDI-DIDate15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
F.S. Test
Generic Name
Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical
Model / Reference
00857
Primary DI / UDI-DI
03607450008579
Basic UDI-DI
B-03607450008579
510(k) Number
FDA Product Code
JBN
EMDN Code
W0103020502 Fibrinogen degradation products
GMDN Term
Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
864.7300
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Category: Soluble fibrin monomer complex IVD, kit, rapid agglutination, clinical

Cleared under the same submission (K854015)

Other devices from Diagnostica Stago, Inc.

See all devices from Diagnostica Stago, Inc. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No