FDA.reportPublic FDA data

BIOPORTO DIAGNOSTICS A/S

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107399813010739981BIOPORTO DIAGNOSTICS A/S1N2026-01-01Tuborg Havnevej 15, st Hellerup Hovedstaden DK 2900

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
05711435000156ProNephro AKI™ (NGAL) Reagent Kit - ST101UB+4545290000ra@bioporto.com
05711435000163ProNephro AKI™ (NGAL) Calibrator Kit - ST102UA+4545290000ra@bioporto.com
05711435000170ProNephro AKI™ (NGAL) Control Kit - ST103UA+4545290000ra@bioporto.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3250541303804097K232761ProNephro AKI™ (NGAL)PIG2023-12-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PIG12023-12-07

GUDID#