Catalog Number

HE0016S

Brand Name

Helix Elite™ Molecular Standards: Synthetic Standard

Version/Model Number

HE0016S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OHQ

Product Code Name

Multi-analyte controls unassayed

Public Device Record Key

a75b3148-b4fe-4049-946c-193b29c59f0f

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

April 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-