Alinity m STI CTRL Kit

Alinity m STI CTRL Kit
Alinity m - 09N17-085

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).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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