Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Device Code: 3152

Product Code(s): QEP

Definition: A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Speci

Device Classification Information

Device Type ID3152
Device NameNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Physical StateIn Vitro Diagnostic Device Consisting Of Reagents And Associated Instrumentation For The Detection Of Nucleic Acid Sequences From Mycoplasma Genitalium In Clinical Specimens.
Technical MethodIn Vitro Diagnostic Device That Detects And Identifies Nucleic Acid Sequences From Mycoplasma Genitalium In Clinical Specimens.
Target AreaClinical Specimens From Patients Suspected Of Mycoplasma Genitalium Infection.
Regulation Medical SpecialtyMolecular Genetics
Review PanelMicrobiology
Submission Type510(k)
CFR Regulation Number866.3393 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeQEP
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID3152
DeviceNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Product CodeQEP
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number866.3393 [🔎]
Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
 
GRANTED
1
TPLC Last Update: 2019-04-02 20:24:39

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.