Biobase
8 catalogue numbers from R1:40mL×2 R2:20mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase. 2 manufacturers in China are registered for this product code.
5-Amp-Phosphate Release (Colorimetric Test), 5′-Nucleotidase
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jilin and Shandong: 2 hold an FDA registration.
- Biobase Biodustry(Shandong)Co., Ltd. Shandong
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
How Is CED Classified?
5-Amp-Phosphate Release (Colorimetric Test), 5′-Nucleotidase is FDA product code CED, Class 1, 21 CFR 862.1520.
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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