Dna-Reagents, Legionella
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
How Is LQH Classified?
Dna-Reagents, Legionella is FDA product code LQH, Class 2, 21 CFR 866.3300.
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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