Who else makes this device?

Name: ABX Pentra Glucose HK CP
Brand: ABX Pentra Glucose HK CP

Clinical Chemistry › Test SystemsHexokinase, Glucose

ABX Pentra Glucose HK CP

Catalogue number 1220001667, listed by Horiba ABX SAS, France, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

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 ABX Pentra Glucose HK CP
Listed by	Horiba ABX SAS, France
FDA product code	CFR
Device type	Hexokinase, Glucose
Device class	Class 2
Regulation	21 CFR 862.1345
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K052007
Record published	2016-08-23
Record revised	2023-07-06 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for ABX Pentra Glucose HK CP
Catalogue number	Size	Status
1220001667		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K103788	2011-11-08
K081276	2008-09-12
K052007	2005-12-16

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of ABX Pentra Glucose HK CP
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Horiba Instruments Incorporated	510(k) number	2016-01-11	Class II	Under Investigation by firm	N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with t	216	2016-06-07

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.