HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests

HSV I and II IgG Ab
IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgG - 10381274

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using a chemiluminescent immunoassay method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LGC

Device Name: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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 Id: 00630414964171

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