Catalog Number

00020500300

Brand Name

HemosIL D-Dimer HS 500

Version/Model Number

0020500300

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

DAP

Product Code Name

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Public Device Record Key

597142b3-3259-43d3-aa91-389b0427d9e6

Public Version Date

July 13, 2021

Public Version Number

3

DI Record Publish Date

June 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-