Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther® System.
Aptima® - KIT, ATV-V2, ROOM TEMP, 100T
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Trichomonas vaginalis in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
- 30.00
- 15.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 15420045505520
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