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FDA-PMA

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

PMA-Nummer: P020011 · 2020-07-21

AntragstellerGen-Probe
Entscheidungsdatum2020-07-21
PMA-NummerP020011
ProduktcodeMZP
GeräteklasseKlasse 2
Medizinische FachrichtungM
Verordnungsnummer21 CFR 8
BeratungsausschussMI

Produktübersicht

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe. It received FDA 510(k) clearance on 2020-07-21. The device is classified under product code MZP. It was reviewed by the MI advisory panel.

Häufig gestellte Fragen

What is the Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Gen-Probe.

When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

The FDA 510(k) record lists Gen-Probe as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus?

The FDA product code for Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is MZP.

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