AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System - The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus - ZEUS SCIENTIFIC, INC.

Duns Number:080953946

Device Description: The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is inten The ZEUS AtheNA Multi-Lyte® Herpes Simplex Virus (HSV)-1 & 2 IgG Plus Test System is intended for the qualitative detection of presence or absence of IgG antibodies to HSV-1 and HSV-2 in human serum. The test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The predictive value of positive or negative results depends on the population’s prevalence and the pretest likelihood of HSV-1 and HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, for use by point of care facilities or for use with automated equipment. This test is for In Vitro diagnostic use only.

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More Product Details

Catalog Number

A97101G

Brand Name

AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System

Version/Model Number

A97101G

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

50ef6b8a-7a5b-4267-a547-21f513726073

Public Version Date

March 29, 2018

Public Version Number

2

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