| Medical devices; immunology and microbiology devices; classification of respiratory viral panel multiplex nucleic acid assay. Final rule. | |
| | |
MedLine Citation:
|
PMID: 19877377 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
|
The Food and Drug Administration (FDA) is announcing the classification of the respiratory viral panel multiplex nucleic acid assay into class II (special controls). The special controls that will apply to the device are three guidance documents entitled: "Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay," as applicable, "Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays," and as applicable,"Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' The agency classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance documents that will serve as the special controls for this device. |
| | |
Authors:
|
|
Related Documents
:
|
19781627 - Loop mediated isothermal amplification combined with nucleic acid lateral flow strip fo... 19028097 - Efficient nucleic acid transduction with lipoplexes containing novel piperazine- and po... 19377997 - Nucleic acid pool preparation and characterization. 18641647 - Plasmacytoid dendritic cells: sensing nucleic acids in viral infection and autoimmune d... 2338637 - Simultaneous derivative spectrophotometric determination of aztreonam and l-arginine in... 6475827 - The effects of a commercial dietary supplement on human performance. |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Federal register Volume: 74 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2009 Oct |
Date Detail:
|
Created Date: 2009-10-30 Completed Date: 2009-11-06 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
|
Languages: eng Pagination: 52136-8 Citation Subset: T |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Device Approval Equipment Safety / classification Humans Influenza A virus / classification* Influenza, Human / classification*, diagnosis Nucleic Acid Amplification Techniques / classification*, instrumentation Nucleic Acids / diagnostic use RNA, Viral / diagnostic use Respiratory Tract Infections / classification*, diagnosis, virology United States United States Food and Drug Administration Virology / instrumentation* |
| Chemical | |
Reg. No./Substance:
|
0/Nucleic Acids; 0/RNA, Viral |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Interim final rules prohibiting discrimination based on genetic information in health insurance cove...
Next Document: Medical devices; clinical chemistry and clinical toxicology devices; classification of the cardiac a...