Who else makes this device?

Name: AST (Sgot) Reagent SET (UV-Kinetic Method)
Brand: AST (Sgot) Reagent SET (UV-Kinetic Method)

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

AST (Sgot) Reagent SET (UV-Kinetic Method)

The AST (SGOT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

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 AST (Sgot) Reagent SET (UV-Kinetic Method)
Listed by	Teco Diagnostics, 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, Manufacturer, Exporter
510(k)	K875071
Record published	2023-07-20

Specifications

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

Catalogue Numbers

Catalogue numbers for AST (Sgot) Reagent SET (UV-Kinetic Method)
Catalogue number	Size	Status
A560-400		In distribution
A560-240		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
K981650	1998-06-29

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.