Catalog Number

BP7564

Brand Name

OPTI CCA E-Glu Cassette

Version/Model Number

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

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

K131126

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

771fe4a7-1beb-47af-81a8-058038caf8a8

Public Version Date

September 11, 2019

Public Version Number

1

DI Record Publish Date

September 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-