Catalog Number

80109

Brand Name

OPTIGEN® US Panel Control Reagent

Version/Model Number

80109

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

DGC

Product Code Name

IGE, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

cc00bfd1-279d-4d05-b90d-e7d3b6573d37

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-