Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

Device Code: 3555

Product Code(s): PCH

Definition: A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Dete

Device Classification Information

Device Type ID3555
Device NameGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Physical StateGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay Systems Are Devices That Consist Of Reagents And Instruments For The Simultaneous Detection And Identification Of Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Huma
Technical MethodA Qualitative In Vitro Diagnostic Assay Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial N
Target AreaIn Vitro Diagnostic Device
Regulation DescriptionGastrointestinal Microorganism Multiplex Nucleic Acid-based Assay.
Regulation Medical SpecialtyMicrobiology
Review PanelMicrobiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number866.3990 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePCH
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3555
DeviceGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Product CodePCH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Microorganism Multiplex Nucleic Acid-based Assay.
CFR Regulation Number866.3990 [🔎]
Premarket Reviews
ManufacturerDecision
APPLIED BIOCODE, INC.
 
SUBSTANTIALLY EQUIVALENT
1
BD
 
SUBSTANTIALLY EQUIVALENT
3
BECTON, DICKINSON & CO.
 
SUBSTANTIALLY EQUIVALENT
3
BECTON, DICKINSON AND COMPANY
 
SUBSTANTIALLY EQUIVALENT
3
BIOFIRE DIAGNOSTICS
 
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX SA
 
SUBSTANTIALLY EQUIVALENT
2
CEPHEID
 
SUBSTANTIALLY EQUIVALENT
1
GREAT BASIN SCIENTIFIC, INC.
 
SUBSTANTIALLY EQUIVALENT
1
LUMINEX CORPORATION
 
SUBSTANTIALLY EQUIVALENT
4
LUMINEX MOLECULAR DIAGNOSTICS
 
SUBSTANTIALLY EQUIVALENT
4
NANOSPERE,INC.
 
SUBSTANTIALLY EQUIVALENT
1
NANOSPHERE, INC
 
SUBSTANTIALLY EQUIVALENT
1
Recalls
Manufacturer Recall Class Date Posted
1
Luminex Corporation
II Oct-11-2018
2
Nanosphere, Inc.
II Sep-23-2014
TPLC Last Update: 2019-04-02 20:32:20

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