Catalog Number

MUG-60

Brand Name

Mumps IgG Test System, 60 Tests

Version/Model Number

MUG-60

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 08, 2022

Issuing Agency

In HIBCC

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

-

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

K894624

Product Code

GRA

Product Code Name

Antiserum, Fluorescent, Mumps Virus

Public Device Record Key

138a3a38-8f7c-4e1a-9f48-e6ff92ec64a5

Public Version Date

March 09, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-