Catalog Number

M12018

Brand Name

Mast Assure Antisera

Version/Model Number

M12018

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

-

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

GNA

Product Code Name

Antisera, All Types, Escherichia Coli

Public Device Record Key

14313c61-c11b-43cc-84c2-5607b20f0e0c

Public Version Date

May 24, 2019

Public Version Number

1

DI Record Publish Date

May 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-