OZB · Class II · 21 CFR 866.3946

FDA Product Code OZB: Dengue Nucleic Acid Amplification Assay (naat)

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).

Leading manufacturers include Centers For Disease Control and Prevention.

Total

Cleared

73d

Avg days

2012

Since

FDA 510(k) Cleared Dengue Nucleic Acid Amplification Assay (naat) Devices (Product Code OZB)

1 devices

1–1 of 1

Not Cleared May 24, 2012

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

DEN120012

Centers For Disease Control and Prevention

Microbiology · 73d

About Product Code OZB - Regulatory Context

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Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: May 24, 2012

Product Code Info

Code	OZB
Device class	Class II
CFR	21 CFR 866.3946
Panel	Microbiology

Verify on FDA.gov

View OZB classification on FDA.gov →