Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027320620

FEI Number

3027320620

Entity Name

Q-linea AB

City/State/Country

Uppsala, SE

Establishment Address

Palmbladsgatan 1, Uppsala 754 50, SE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Q-linea AB (Owner Number: 10091083)

Owner / Operator Contact Address

Dag Hammarskjolds vag 52A, Uppsala, SE-C 75237, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221688

PMA Number

N/A

All Registered Proprietary Names

ASTar System ASTar BC G- Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2024-06-27
SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	Class 2	866.1650	2024-06-27

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Myers Email: michelle.myers@qlinea.com Phone: (570) 3168943

Related Public Records

Same Entity

Q-linea AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

Similar Registrations

Registration Number	Establishment Name	Location
3013718871	UPS Supply Chain Solutions, Inc.	Pedricktown, NJ, US
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US
1950204	BIOMERIEUX, INC.	HAZELWOOD, MO, US
3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027320620. Last updated year: 2026. Please use registration number 3027320620 when referencing this establishment in official correspondence.