AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System - The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - - ZEUS SCIENTIFIC, INC.

Duns Number:080953946

Device Description: The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus T The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus - Viral Capsid Antigen (EBV-VCA) IgM Plus Test System is a microparticle-based immunoassay intended for the qualitative detection of IgM class antibody to the Epstein-Barr virus, viral capsid antigen in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used for the laboratory diagnosis of EBV-associated infectious mononucleosis and provides epidemiological information on the diseases caused by Epstein-Barr virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.

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More Product Details

Catalog Number

A92101M

Brand Name

AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System

Version/Model Number

A92101M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

4416547d-5f8e-47ec-bb6f-303c7345bd7b

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEUS SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1