Sweat Control Level 1, 2, & 3 Set 9x3ml
The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures…
Electrolyte Controls (Assayed and Unassayed)
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Chongqing, Jilin and Shanghai: 3 hold an FDA registration.
- Chong Qing Teco Huayi Pharm. Co. Chongqing, contract manufacturer
- Dirui Industrial Co., Ltd. Jilin, contract manufacturer
- Infitek Co., Ltd. Shanghai
What Is FDA Product Code JJR?
Electrolyte Controls (Assayed And Unassayed) is FDA product code JJR, Class 1, 21 CFR 862.1660.
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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