Catalog Number

97000HSEU

Brand Name

Triage

Version/Model Number

97000HSEU

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

DOR

Product Code Name

RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.

Public Device Record Key

d6c9a5fd-93fc-4a56-a978-957f1df54e8b

Public Version Date

April 03, 2020

Public Version Number

2

DI Record Publish Date

November 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-