FDA.reportPublic FDA data

Q-linea AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30273206203027320620Q-linea AB1N2026-01-01Palmbladsgatan 1 Uppsala SE 754 50

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
07350136800047ASTar Instrument - Antimicrobial Susceptibility Testing+1 5703168943support@qlinea.com
07350136800047ASTar Instrument - Antimicrobial Susceptibility Testing+4618235000order@qlinea.com
07350136800054ASTar BC G- Kit software - Antimicrobial Susceptibility Testing - Gram negative+4618235000order@qlinea.com
07350136800054ASTar BC G- Kit software - Antimicrobial Susceptibility Testing - Gram negative+1 5703168943support@qlinea.com
07350136800061ASTar BC G- Consumable kit - Antimicrobial Susceptibility Testing - Gram negative+4618235000order@qlinea.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3298831110233544K221688ASTar BC G- Kit and ASTar InstrumentSAN2024-04-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SAN12024-04-26

PMN#

GUDID#