Catalog Number

01R0821

Brand Name

Alinity

Version/Model Number

01R0821

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LKL

Product Code Name

ALPHA-1-ACID-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

c9047363-2442-4393-95a1-31e3c66be501

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

April 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-