Catalog Number

10720846

Brand Name

ADVIA Centaur Herpes-1 IgG

Version/Model Number

10720846

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181333

Product Code

MXJ

Product Code Name

Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1

Public Device Record Key

fa6402f3-1cfc-4588-834e-3cbf7ebb1f57

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

April 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-