Catalog Number

66003

Brand Name

Whole Blood Calibration Standard

Version/Model Number

66003

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

-

Product Code

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

a4214a7a-9739-4416-b077-086651dc462b

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Package DI Number

04250317514035

Quantity per Package

5

Contains DI Package

04250317544070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-