Catalog Number

-

Brand Name

TRUE METRIX

Version/Model Number

TRUE METRIX Control Solution Level 1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

56273827-30f2-44d9-bd0e-779da285d64b

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

00021292006235

Quantity per Package

1

Contains DI Package

00021292008390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX