Antisera, Fluorescent, Human Metapneumovirus

Device Code: 3528

Product Code(s): OMG

Definition: It Is Intended For The Qualitative Detection And Identification Of Human Metapneumovirus (hMPV) In Direct Respiratory Specimens Or Cell Culture. The Assay Detects HMPV Antigens By Immunofluorescence Using Antibodies, From Patients With Signs And Symp

Device Classification Information

• Device Type ID: 3528
• Device Name: Antisera, Fluorescent, Human Metapneumovirus
• Physical State: HMPV DSFA, HMPV DFA
• Technical Method: The Assay Detects HMPV Antigens By Immunofluorescence Using Antibodies.
• Target Area: Direct Clinical Speciemns Or Cell Culture Amplified Speciemns
• Regulation Description: Respiratory Viral Panel Multiplex Nucleic Acid Assay.
• 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: 866.3980 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OMG
• 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: 3528
• Device: Antisera, Fluorescent, Human Metapneumovirus
• Product Code: OMG
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Respiratory Viral Panel Multiplex Nucleic Acid Assay.
• CFR Regulation Number: 866.3980 [🔎]

TPLC Last Update: 2019-04-02 20:31:46