Who else makes this device?

Name: Aspartate Aminotransferase acc to Ifcc without pyridoxal phosphate activation
Brand: Aspartate Aminotransferase acc to Ifcc without pyridoxal phosphate activation

Clinical Chemistry › Test SystemsNadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Acc to Ifcc Without Pyridoxal Phosphate Activation

2 catalogue numbers from 5850819190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

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 Aspartate Aminotransferase acc to Ifcc without pyridoxal phosphate activation
Listed by	Roche Diagnostics Gmbh, Germany
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, Manufacturer, Exporter
510(k)	K951595
Record published	2016-09-20
Record revised	2023-07-06 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Aspartate Aminotransferase acc to Ifcc without pyridoxal phosphate activation
Catalogue number	Size	Status
5850819190		In distribution
20764949322		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K071211	2007-07-30

Recalls

The FDA has not published a severity grade for these. 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
2004-08-20	Not classified	Other	Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.	757non-expired kits.	2004-11-05
2004-07-14	Not classified	Other	Coating defect may result is falsely decreased patient and/or control results.	197 boxes	2004-10-14

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.