Who else makes this device?

Name: Aspartate Aminotransferase Test Strip
Brand: Aspartate Aminotransferase Test Strip

Clinical Chemistry › Test SystemsHydrazone Colorimetry, Ast/Sgot

Aspartate Aminotransferase Test Strip

3 catalogue numbers from PS 92.25 strips/vial ×4/box, listed by Urit Medical Electronic Co., Ltd., China, under Hydrazone Colorimetry, Ast/Sgot. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

3catalogue 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 Test Strip
Listed by	Urit Medical Electronic Co., Ltd., China
FDA product code	CIS
Device type	Hydrazone Colorimetry, Ast/Sgot
Device class	Class 2
Regulation	21 CFR 862.1100
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2026-06-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for Aspartate Aminotransferase Test Strip
Catalogue number	Per pack	Status
PS 92.25 strips/vial ×4/box	100	In distribution
PS 92B,25 strips/vial ×4/box	100	In distribution
PS 92A,25 strips/vial ×4/box	100	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aspartate Aminotransferase (AST)	Randox Laboratories Limited	2

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.