Acid, Alpha-Ketobutyric and Nadh (U.V.), Hydroxybutyric Dehydrogenase

Who Makes This Device Type in China?

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

What Is FDA Product Code JMK?

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase is FDA product code JMK, Class 1, 21 CFR 862.1380.

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.

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

PTS Panels® Ketones Test Strips

PTS Panels® Ketone test strips are in vitro diagnostic devices used to monitor ketone levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand…

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

Liquid Ranbut (RBT)

For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

13 catalogue numbers from R1:48mL×2 R2:12mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase. 2 manufacturers in China are registered for this product code.

Acid, Alpha-Ketobutyric and Nadh (U.V.), Hydroxybutyric Dehydrogenase

Who Makes This Device Type in China?

What Is FDA Product Code JMK?

What Does It Take to Sell It in the United States?

PTS Panels® Ketones Test Strips

Liquid Ranbut (RBT)

Biobase

Where China Actually Supplies