Catalog Number

01-085005

Brand Name

D3

Version/Model Number

01-085005

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

K063798

Product Code

GQN

Product Code Name

Antigen, cf (including cf control), herpesvirus hominis 1,2

Public Device Record Key

dc2a33b7-304b-4b44-a65d-3b2417a1fb67

Public Version Date

August 22, 2018

Public Version Number

1

DI Record Publish Date

July 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-