Catalog Number

-

Brand Name

Protein 3 Calibration verifier Set for the Roche Integra

Version/Model Number

98503

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

K030566

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

a1699ddc-0210-4c32-aaa7-9b7dc2fc876a

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

January 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-