Catalog Number

01-075010

Brand Name

D3

Version/Model Number

01-075010

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

K081164

Product Code

LIN

Product Code Name

ANTISERA, CONJUGATED FLUORESCENT, CYTOMEGALOVIRUS

Public Device Record Key

1e01374d-cef1-424f-a915-c1b3e260d008

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-