Teco Diagnostics Lipase Reagent Set
Teco Diagnostics Lipase Reagent Set is used for the quantitative turbidimetric determination of pancreatic lipase in human serum.
Olive Oil Emulsion (Turbidimetric), Lipase
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is FDA Product Code CET?
Olive Oil Emulsion (Turbidimetric), Lipase is FDA product code CET, Class 1, 21 CFR 862.1465.
What Does It Take to Sell It in the United States?
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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