510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OUZClass I

Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids

21 CFR 866.3870 / Microbiology
FDA source (opens on fda.gov)

OUZ is the FDA product code for Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids, a class I device type, regulated under 21 CFR 866.3870. FDA's definition for this code reads: "Detection of Leishmania species in skin lesions". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OUZ
Device name
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
FDA definition
Detection of Leishmania species in skin lesions.
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OUZ

By decision year
1 clearance under product code OUZ with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OUZ by decision year
YearClearances
20111

Applicants with the most clearances

Product code OUZ
Applicants holding the most 510(k) clearances under product code OUZ
ApplicantClearances
U.S. Army Medical Research Institute of Infectious1

Companies listing this code with FDA

Companies whose registered establishments list this code