Who else makes this device?

Name: Glucose (HK)
Brand: Glucose (HK)

Clinical Chemistry › Test SystemsHexokinase, Glucose

Glucose (HK)

For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code CFR
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Roche Diagnostics (Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	3

Record

Regulatory record for Glucose (HK)
Listed by	Thermo Fisher Scientific OY, Finland
FDA product code	CFR
Device type	Hexokinase, Glucose
Device class	Class 2
Regulation	21 CFR 862.1345
Establishment	Contract manufacturer, Manufacturer
510(k)	K110035
Record published	2016-08-30
Record revised	2023-07-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
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 Glucose (HK)
Catalogue number	Size	Status
NONE		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Gluc-HK	Randox Laboratories Limited	6
Glucoquant GlucoseHK	Roche Diagnostics Gmbh	3
Glucose HK	Roche Diagnostics Gmbh	3
AU	Beckman Coulter, Inc.	3
Teco Diagnostics Glucose (Hexokinase) Reagent Set	Teco Diagnostics	2
Yumizen C1200 Glucose HK	Horiba ABX SAS	2
Architect	Abbott Laboratories	2
Alinity	Abbott Medical	2
Teco Diagnostics Glucose (Hexokinase) Liquid Reagent	Teco Diagnostics	2
Atellica CH GluH_3	Siemens Healthcare Diagnostics Inc	2
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Architect	Abbott Medical	2

Showing 12 of 43. All products under Hexokinase, Glucose

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.