Asserachrom® Protein C
Catalogue number 00944, listed by Diagnostica Stago, Inc., United States, under Conversion To Creatinine, Creatine. 3 manufacturers in China are registered for this product code.
Conversion to Creatinine, Creatine
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, based in Jilin. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Changchun Merydi BIO-Tech Co., Ltd. Jilin
- Changchun Wancheng BIO-Electron Co., Ltd. Jilin, contract manufacturer
- Jilin Hongyi BIO-Tech Co., Ltd. Jilin
What Is FDA Product Code JLA?
Conversion To Creatinine, Creatine is FDA product code JLA, Class 1, 21 CFR 862.1210.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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