Catalog Number

-

Brand Name

IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL)

Version/Model Number

IT3861

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)

-

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

e3e5c2f8-e1da-4192-926e-c03d157cf24b

Public Version Date

June 11, 2019

Public Version Number

1

DI Record Publish Date

June 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-