Catalog Number

-

Brand Name

AggreDYNE AA Assay

Version/Model Number

A-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOZ

Product Code Name

System, Automated Platelet Aggregation

Public Device Record Key

ada84b0d-15e2-4956-9608-c381fe0e0224

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Package DI Number

20856893004014

Quantity per Package

20

Contains DI Package

00856893004010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case