Who else makes this device?

Name: Liaison® XL
Brand: Liaison® XL

Clinical Chemistry › Laboratory InstrumentsAnalyzer, Chemistry, Micro, For Clinical Use

Liaison® XL

Catalogue number I0050, listed by Diasorin Inc., United States, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (1), Hubei (1), Henan (1).

Chinese manufacturers registered for FDA product code JJF
Manufacturer	City	Province	Registered as	Device types
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Wuhan Landing Intelligence Medical Co., Ltd.	Wuhan	Hubei	Manufacturer	17
Autobio Labtec Instruments Co., Ltd.	Zhengzhou	Henan	Manufacturer	3

Record

Regulatory record for Liaison® XL
Listed by	Diasorin Inc., United States
FDA product code	JJF
Device type	Analyzer, Chemistry, Micro, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2170
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K103529
Record published	2016-09-24
Record revised	2026-01-19 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Liaison® XL
Catalogue number	Size	Status
I0050		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Diamedix	Diamedix Corp.	2
Spotcheck	Astoria-Pacific, Inc.	2
Cholestech LDX™	Alere San Diego, Inc.	2
AWS	Randox Laboratories Limited	1
COBAS®TaqMan® 48 Analyzer	Roche Molecular Systems, Inc.	1
Soln Wash	Randox Laboratories Limited	1
Wash conc. 1	Randox Laboratories Limited	1
NS	Randox Laboratories Limited	1
Liaison® Easy Starter Kit	Diasorin S.P.A	1
Rabs	Randox Laboratories Limited	1
Cl Soln	Randox Laboratories Limited	1
Wash Concentrate 2	Medtest DX	1

Showing 12 of 26. All products under Analyzer, Chemistry, Micro, For Clinical Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K052794	2006-03-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.