The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests.

The MERIFLUOR EBV
MERIFLUOR EBV-NA - EN100

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 a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LLM

Device Name: Test, Antigen, Nuclear, Epstein-Barr Virus

Device Class: 1

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: 866.3235

Third Party Flag: Y

Medical Specialty: MI

Device Id: 00840733101953

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