510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN120012Unknown

Cdc Denv-1-4 Real Time Rt-Pct Assay

Centers for Disease Control and Prevention, Atlanta GA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN120012 is the FDA 510(k) clearance record for CDC DENV-1-4 REAL TIME RT-PCT ASSAY, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code OZB (Dengue Nucleic Acid Amplification Assay (Naat)). FDA's definition for product code OZB 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)". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming DEN120012.

Clearance record

Decision date
Received
(73 days to decision)
Product code
OZB Dengue Nucleic Acid Amplification Assay (Naat)
Regulation
21 CFR 866.3946
Device class
Class II
Review panel
Microbiology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd., NE, Atlanta GA
Third party review
No

Clearances, product code OZB

Trailing 12 months

FDA records hold no clearances under product code OZB in the trailing twelve months.

FDA records show no clearances under product code OZB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OZB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260