Catalog Number

-

Brand Name

MeMed BV® External Control

Version/Model Number

FG12001

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)

-

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

K210254

Product Code

QPS

Product Code Name

Immunoassay For Host Biomarkers Of Infection

Public Device Record Key

3ca5608d-1fd4-4dda-9818-5ae993faaaf8

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-