Lipoprotein (A) (Lp (A))
2 catalogue numbers from LP8054, listed by Randox Laboratories Limited, United Kingdom, under System, Test, Lipoprotein(A). 2 manufacturers in China are registered for this product code.
System, Test, Lipoprotein(A)
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Hebei and Jilin: 2 hold an FDA registration.
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
- Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei
What Is FDA Product Code MSM?
System, Test, Lipoprotein(A) is FDA product code MSM, Class 1, 21 CFR 862.1475.
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.
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