ANTI-EBV

ANTI-EBV - AM222-5M

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunohistochemistry method The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Environmental Conditions

Special Storage Condition, Specify

Store at 2-8°C

Device Sizes

Total Volume: 6 Milliliter

Total Volume: 6 Milliliter

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NJT

Device Name: Immunohistochemistry Reagents And Kits

Device Class: 1

Physical State: N/A

Definition: according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.

Submission Type ID: 4

Review Panel: PA

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: 864.1860

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 00810119672100

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