Catalog Number

07027508190

Brand Name

Elecsys HSV-2 IgG

Version/Model Number

07027508190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K121895

Product Code

MYF

Product Code Name

Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Public Device Record Key

613b53e9-2474-4f70-8dbf-a4917859b455

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-