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 | ||
|---|---|---|
| Manufacturer | Decision | |
HOLOGIC, INC. | ||
GRANTED | 1 | |