Catalog Number

98015XR

Brand Name

Triage

Version/Model Number

98015XR

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

K000231

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

2433acc6-cc82-486f-b20a-59a18d4aa51b

Public Version Date

June 11, 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

-