APTIMA

APTIMA - TRICHOMONAS VAGINALIS, 250T, IVD (REF)V2

A collection of reagents and other associated materials 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

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OUY

Device Name: Trichomonas Vaginalis Nucleic Acid Amplification Test System

Device Class: 2

Physical State: May include target capture, transcription-mediated amplification, semi automated analyzer

Definition: In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses target capture, transcription-mediated amplification and hybridization protection assay technologies to stream line specimen processing, amplify target rRNA and detect amplicon respectively

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Vaginal, cervical,endocervical, urogenital and gynecological specimens

Regulation Number: 866.3860

Third Party Flag: N

Medical Specialty: IM

Device Id: 15420045505551

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