OUZ

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

Product code

OUZ

Device name

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

Device class

Class 1

21 CFR

21 CFR 866.3870

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Detection of Leishmania species in skin lesions.

Definition text from the FDA device classification database (U.S. federal government work, public domain).