Catalog Number

755725

Brand Name

MONO, MERIDIAN IMMUNO 25 Test Kit

Version/Model Number

755725

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

KTN

Product Code Name

SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Public Device Record Key

32ab7d50-50b8-4f27-8f90-94969f41570a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-