Catalog Number

M12014

Brand Name

Mast Assure Escherichia coli O26 antiserum

Version/Model Number

M12014

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)

Yes

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

GNA

Product Code Name

Antisera, All Types, Escherichia Coli

Public Device Record Key

a7c386e2-2a7d-4a0f-9a7c-442e8389e73d

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-