Catalog Number

08P2801

Brand Name

Alinity

Version/Model Number

08P2801

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

K063329

Product Code

LOL

Product Code Name

Hepatitis a test (antibody and igm antibody)

Public Device Record Key

d4ac1847-ddcf-47db-ba68-5ae11341d4bf

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

January 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-