Cast® Wash Buffer Basophil
CAST® Wash Buffer Basophil (B-CCR-WB10) is a formalin-saline solution used to wash, fixate and reconstitute basophils in basophil activation assays, ensuring proper sample preparation for…
Formalin-Saline
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Yancheng Trancom First AID Supplies Industrial Co., Ltd. Jiangsu, contract manufacturer
How Is IGC Classified?
Formalin-Saline is FDA product code IGC, Class 1, 21 CFR 864.4010.
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. It is also exempt from most of the quality system regulation.
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