Who else makes this device?

Name: Dimension® Flex® reagent cartridge AST
Brand: Dimension® Flex® reagent cartridge AST

Dimension® Flex® Reagent Cartridge AST · Nadh Oxidation/Nad Reduction, Ast/Sgot → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

2recalls on this code

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CIT
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for Dimension® Flex® reagent cartridge AST
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	CIT
Device type	Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class	Class 2
Regulation	21 CFR 862.1100
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K112999
Record published	2016-09-24
Record revised	2023-07-06 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Dimension® Flex® reagent cartridge AST
Catalogue number	Size	Per pack	Status
10444959		4	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	19
AST	Randox Laboratories Limited	10
JAS Diagnostics	Drew Scientific, Ltd.	7
Synermed®	Infrared Laboratory Systems LLC	7
Pointe Scientific, Inc.	Horiba Instruments Incorporated	5
AU	Beckman Coulter, Inc.	4
Architect	Abbott Ireland	4
Synchron	Beckman Coulter, Inc.	4
ACE	Alfa Wassermann	4
Architect	Abbott Medical	3
Alinity	Abbott Ireland	3
Architect	Abbott Laboratories	3

Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Dimension® Flex® reagent cartridge AST
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Siemens Healthcare Diagnostics Inc	510(k) number	2017-06-29	Class II	Device Design	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.	181,072	2020-04-23

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
2017-06-29	Class II	Device Design	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.	32,744	2020-04-23

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.

Dimension® Flex® Reagent Cartridge AST