Catalog Number

HE0058-DN

Brand Name

Helix Elite™ Molecular Standards: Inactivated Standard

Version/Model Number

HE0058-DN

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)

-

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

219222ac-345d-4b84-abf1-bf6a62d8ac8f

Public Version Date

December 25, 2020

Public Version Number

1

DI Record Publish Date

December 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-