Catalog Number

08P0501

Brand Name

Alinity

Version/Model Number

08P0501

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

P050042

Product Code

MZO

Product Code Name

Assay, enzyme linked immunosorbent, hepatitis c virus

Public Device Record Key

f66b102d-6756-435b-80e3-899423476a7b

Public Version Date

June 22, 2020

Public Version Number

2

DI Record Publish Date

October 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-