HiNasal
Catalogue number DP-200, listed by Mainiusi Intelligent Medical Technology (Suzhou) Co., Ltd., China, under Antiserum, Positive Control, Blastomyces Dermatitidis. 1 manufacturer in China is registered for this product code.
Antiserum, Positive Control, Blastomyces Dermatitidis
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
How Is KFH Classified?
Antiserum, Positive Control, Blastomyces Dermatitidis is FDA product code KFH, Class 2, 21 CFR 866.3060.
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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