Aptima® BV Assay Controls Kit.

Aptima® BV Assay Controls Kit.
Aptima® - BV CONTROLS, APTIMA, 100T, IVD

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 organisms associated with vaginitis in a clinical specimen. Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PQA

Device Name: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Device Class: 2

Physical State: In vitro device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.

Definition: A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Qualitative in vitro diagnostic device that detects nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro diagnostic device

Regulation Number: 866.3975

Third Party Flag: N

Medical Specialty: MI

Code: NSU

Device Name: Instrumentation For Clinical Multiplex Test Systems

Device Class: 2

Physical State: N/A

Definition: Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2570

Third Party Flag: N

Medical Specialty: CH

Code: PMN

Device Name: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Device Class: 2

Physical State: solid or liquid

Definition: Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: For use with nucleic acid amplification microbiology assays

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable - Single or multi-analyte

Regulation Number: 866.3920

Third Party Flag: Y

Medical Specialty: MI

Device Id: 15420045512054

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