Who else makes this device?

Name: Creatine Kinase
Brand: Creatine Kinase

Clinical Chemistry › Test SystemsEnzymatic Method, Creatinine

Creatine Kinase

Catalogue number 5168546190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Method, Creatinine. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Zhejiang (1), Guangxi (1), Chongqing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JFY
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Chong Qing Teco Huayi Pharm. Co.	Shapingba Dist.	Chongqing	Contract manufacturer	18

Record

Regulatory record for Creatine Kinase
Listed by	Roche Diagnostics Gmbh, Germany
FDA product code	JFY
Device type	Enzymatic Method, Creatinine
Device class	Class 2
Regulation	21 CFR 862.1225
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K812095
Record published	2016-09-20
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Creatine Kinase
Catalogue number	Size	Status
5168546190		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Creatinine Plus	Roche Diagnostics Gmbh	3
Teco Diagnostics	Teco Diagnostics	3
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Creatinine plus ver2	Roche Diagnostics Gmbh	3
Architect	Abbott Laboratories	2
CR Cartridge	LifeHealth, LLC	2
Alinity	Abbott Laboratories	2
Creatinine LiquiColor®	Stanbio Laboratory, L.P.	2
Pointe Scientific, Inc. Creatinine Enzymatic	Horiba Instruments Incorporated	2
Automatic Urine Analyzer	Urit Medical Electronic Co., Ltd.	2
Creatinine plus ver.2	Roche Diagnostics Gmbh	1
Dimension® Flex® reagent cartridge Ezcr	Siemens Healthcare Diagnostics Inc	1

Showing 12 of 40. All products under Enzymatic Method, Creatinine

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K024098	2002-12-19
K003261	2000-11-16

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2008-06-11	Not classified	Labeling Change Control	Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.	1068	2009-09-22

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.