Catalog Number

HS2-4012

Brand Name

Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System

Version/Model Number

HS2-4012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K881261

Product Code

GQO

Product Code Name

Antisera, Cf, Herpesvirus Hominis 1,2

Public Device Record Key

4a5b8f65-552e-4571-b948-74207babd3df

Public Version Date

March 04, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-