510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN060008Unknown

Influenza A/h5 (Asian Lineage) Virus Real-Time Rt-PCR Primer and Probe Set

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

DEN060008 is the FDA 510(k) clearance record for INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna). FDA's definition for product code NXD reads: "Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and...". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming DEN060008.

Clearance record

Decision date
Received
(7 days to decision)
Product code
NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Regulation
21 CFR 866.3332
Device class
Class II
Review panel
Microbiology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd. NE (Ms C-12), Atlanta GA
Third party review
No

Clearances, product code NXD

Trailing 12 months

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

FDA records show no clearances under product code NXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXD, 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