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

Dengue Nucleic Acid Amplification Assay (Naat)

21 CFR 866.3946 / Microbiology
FDA source (opens on fda.gov)

OZB is the FDA product code for Dengue Nucleic Acid Amplification Assay (Naat), a class II device type, regulated under 21 CFR 866.3946. FDA's definition for this code reads: "A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OZB
Device name
Dengue Nucleic Acid Amplification Assay (Naat)
FDA definition
A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
Regulation
21 CFR 866.3946
Device class
Class II
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 OZB

By decision year
1 clearance under product code OZB with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OZB by decision year
YearClearances
20121

Applicants with the most clearances

Product code OZB
Applicants holding the most 510(k) clearances under product code OZB
ApplicantClearances
Centers for Disease Control and Prevention1

Companies listing this code with FDA

Companies whose registered establishments list this code