Catalog Number

10736515

Brand Name

EPOC BGEM BUN TEST CARD

Version/Model Number

10736515

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2020

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

-

Product Code Name

-

Public Device Record Key

40cf7eca-d054-44ac-802c-80bb5d0b8f4a

Public Version Date

December 02, 2020

Public Version Number

2

DI Record Publish Date

April 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-