Alinity m STI CTRL Kit
Alinity m - 09N17-085
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).
Environmental Conditions
- -15.00
- -25.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QEP
Device Name: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device Class: 2
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.
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 specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: In vitro diagnostic device that detects and identifies nucleic acid sequences from Mycoplasma genitalium in clinical specimens.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Clinical specimens from patients suspected of Mycoplasma genitalium infection.
Regulation Number: 866.3393
Third Party Flag: N
Medical Specialty: MI
Device Identifiers
Device Id: 00884999048607
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A