Herpes Simplex Virus 1 and 2, 4 Well Slides

Herpes Simplex Virus 1 and 2, 4 Well Slides
Pathfinder - 12000150

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

5 Tests

4 Wells

5 Tests
4 Wells

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: 00847865012768

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