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FDA PMA

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

PMA Number: P100017 · 2021-03-05

ApplicantAbbott Molecular, Inc.
Decision Date2021-03-05
PMA NumberP100017
Product CodeMZP
Device ClassClass 2
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus is the device name listed in this FDA PMA record. The listed applicant is Abbott Molecular, Inc.. It received FDA Premarket Approval (PMA) on 2021-03-05 under PMA number P100017. The device is classified under FDA product code MZP. It was reviewed by the MI advisory panel. This device is classified as Class II by the FDA. Class III devices subject to special controls, in addition to general controls. These devices typically require premarket notification (510(k)). PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of M. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is 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 Premarket Approval (PMA) on 2021-03-05. The listed applicant is Abbott Molecular, Inc.. The PMA number is P100017.

When did Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus receive FDA PMA approval?

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus received FDA PMA approval on 2021-03-05, under PMA number P100017.

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

The FDA PMA record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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.

What FDA device class is 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 classified as Class II by the FDA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07221097Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other CoronavirusesCOMPLETED

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 40801347Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives.Critical reviews in clinical laboratory sciences (2025)

Other records listing Abbott Molecular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230003KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSPMA P170041Somatic gene mutation detection systemPMA P170005Somatic gene mutation detection systemPMA P150041Fluorescence in situ hybridization, chromosome 17p deletion (TP53)PMA P110012Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangementPMA P030052Unknown Device

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Related Devices (Code: MZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252484cobas HCVRoche Molecular Systems, Inc.K252102Alinity m HCVAbbott Molecular, Inc.K233352Aptima HCV Quant Dx AssayHologic, Inc.K221007cobas HCVRoche Molecular Systems, Inc.PMA P060030Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.PMA P150015Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virusRoche Molecular Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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