Who else makes this device?

Name: ABX Pentra AST CP
Brand: ABX Pentra AST CP

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

ABX Pentra AST CP

Catalogue number 1220001629, listed by Horiba ABX SAS, France, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 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

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 ABX Pentra AST CP
Listed by	Horiba ABX SAS, France
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, Complaint-file establishment, Manufacturer, Exporter
510(k)	K060318
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 AST CP
Catalogue number	Size	Status
1220001629		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
K060318	2006-08-08

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 AST CP
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Horiba Instruments Incorporated	510(k) number	2012-10-10	Class II	Software design	Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) we	66886 units	2013-09-12

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.