Aptima® HSV 1 & 2 Assay Controls Kit.

Aptima® HSV 1 & 2 Assay Controls Kit.
Aptima® - KIT, CONTROLS, AHSV, 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OQO

Device Name: Herpes Simplex Virus Nucleic Acid Amplification Assay

Device Class: 2

Physical State: Plasma, serum, swab, culture isolates

Definition: A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Systemic

Regulation Number: 866.3305

Third Party Flag: N

Medical Specialty: MI

Device Id: 15420045507234

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