Catalog Number

-

Brand Name

Dako

Version/Model Number

LX002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2018

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

-

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Public Device Record Key

d9e82626-5647-415e-9b23-a06a0ac1b040

Public Version Date

December 07, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-