Herpes Simplex Virus Types 1 and 2 Direct Antigen Detection System
Pathfinder - 25215
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a fluorescent immunoassay method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- 50 Tests
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GQL
Device Name: Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: MI
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: 866.3305
Third Party Flag: N
Medical Specialty: MI
Device Identifiers
Device Id: 00847865001465
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
