Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna

Device Code: 3518

Product Code(s): NXD

Definition: 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 Differentiation Of S

Device Classification Information

• Device Type ID: 3518
• Device Name: Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna
• Physical State: OIVD
• Technical Method: Direct Nucleic Acid Amplification
• Target Area: Specific RNA Segment
• Regulation Description: Reagents For Detection Of Specific Novel Influenza A Viruses.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.3332 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NXD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3518
• Device: Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna
• Product Code: NXD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Reagents For Detection Of Specific Novel Influenza A Viruses.
• CFR Regulation Number: 866.3332 [🔎]

TPLC Last Update: 2019-04-02 20:31:35