FDA.reportPublic FDA data

Fujirebio Diagnostics AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30272735653027273565Fujirebio Diagnostics AB1N2026-01-01Gemenskapens gata 7 Molndal Vastra Gotaland SE SE-431 53

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
17350066140043Tumor Marker Control - 108-20+4631857030info@fdab.com
17350066140135CYFRA 21-1 EIA - 211-10+4631857030info@fdab.com
17350066140326HE4 EIA - 404-10US+4631857030info@fdab.com
17350066140524Mesothelin Control - 360-20+4631857030info@fdab.com
17350066140531Lung Marker Control - 240-20+46318507030info@fdab.com
17350066140579AMH Control - 660-20+4631857030info@fdab.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3170181416518199K101809FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20JJY2010-10-05
3170181138111564
3170181429607468

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJY12010-10-05

GUDID#