Catalog Number

05A0710

Brand Name

ABBOTT PRISM

Version/Model Number

5A07-10

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MZA

Product Code Name

TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

Public Device Record Key

65a91ad9-66e8-4394-bad9-d83d2782defe

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-