Catalog Number

5277306

Brand Name

LEADER

Version/Model Number

5277306

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132086,K132086,K132086

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

79a1a63c-6fdb-40d5-8631-1c19646b9940

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

April 24, 2017

Package DI Number

30096295129183

Quantity per Package

24

Contains DI Package

00096295129182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX