Who else makes this device?

Name: Aspartate Aminotransferase (AST)
Brand: Aspartate Aminotransferase (AST)

Clinical Chemistry › Test SystemsHydrazone Colorimetry, Ast/Sgot

Aspartate Aminotransferase (AST)

2 catalogue numbers from AS101, listed by Randox Laboratories Limited, United Kingdom, under Hydrazone Colorimetry, Ast/Sgot. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Guangxi.

Chinese manufacturers registered for FDA product code CIS
Manufacturer	City	Province	Registered as	Device types
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28

Record

Regulatory record for Aspartate Aminotransferase (AST)
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	CIS
Device type	Hydrazone Colorimetry, Ast/Sgot
Device class	Class 2
Regulation	21 CFR 862.1100
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2019-06-03
Record revised	2023-07-06 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Aspartate Aminotransferase (AST)
Catalogue number	Size	Status
AS101		In distribution
AS147		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aspartate Aminotransferase Test Strip	Urit Medical Electronic Co., Ltd.	3

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.