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510(k) DEN120012

CDC DENV-1-4 REAL TIME RT-PCT ASSAY by Centers for Disease Control and Prevention — Product Code OZB

DEN120012 is an FDA 510(k) premarket notification submitted by Centers for Disease Control and Prevention for the device "CDC DENV-1-4 REAL TIME RT-PCT ASSAY". The FDA issued a decision of De Novo Granted on May 24, 2012. The device falls under product code OZB (Dengue Nucleic Acid Amplification Assay (Naat)), a Class II device regulated under 21 CFR 866.3946. Centers for Disease Control and Prevention has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 24, 2012
Date Received
March 12, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dengue Nucleic Acid Amplification Assay (Naat)
Device Class
Class II
Regulation Number
866.3946
Review Panel
MI
Submission Type

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).

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  • K200370 — CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typin (March 10, 2020)
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FDA data resources