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 Type ID | 3152 |
Device Name | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
Physical State | In Vitro Diagnostic Device Consisting Of Reagents And Associated Instrumentation For The Detection Of Nucleic Acid Sequences From Mycoplasma Genitalium In Clinical Specimens. |
Technical Method | In Vitro Diagnostic Device That Detects And Identifies Nucleic Acid Sequences From Mycoplasma Genitalium In Clinical Specimens. |
Target Area | Clinical Specimens From Patients Suspected Of Mycoplasma Genitalium Infection. |
Regulation Medical Specialty | Molecular Genetics |
Review Panel | Microbiology |
Submission Type | 510(k) |
CFR Regulation Number | 866.3393 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | QEP |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3152 |
Device | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
Product Code | QEP |
FDA Device Classification | Class 2 Medical Device |
CFR Regulation Number | 866.3393 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
HOLOGIC, INC. | ||
GRANTED | 1 |