Catalog Number

9466

Brand Name

Total Protein/Albumin Standard Kit, Level F

Version/Model Number

9466

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

K882116

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Public Device Record Key

256c661e-34cb-4885-9fb1-19dd922214dc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-