Who else makes this device?

Name: V-Twin®
Brand: V-Twin®

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

V-Twin®

Catalogue number 6002-800, listed by VitalScientific B.V., Netherlands, 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

1recall

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 V-Twin®
Listed by	VitalScientific B.V., Netherlands
FDA product code	JJF
Device type	Analyzer, Chemistry, Micro, For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2170
Establishment	Contract manufacturer, Manufacturer
Record published	2016-11-21
Record revised	2025-05-07 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Distribution end date	2025-05-06

Catalogue Numbers

Catalogue numbers for V-Twin®
Catalogue number	Size	Status
6002-800		Withdrawn

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
Liaison® XL	Diasorin Inc.	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

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

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2018-09-07	Class II	Device Design	The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indica	192 devices	2022-06-29

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.