Container, Specimen Mailer and Storage, Temperature Controlled, Sterile

How Is NNL Classified?

Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile is FDA product code NNL, Class 1, 21 CFR 864.3250.

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.