Catalog Number

6800368

Brand Name

VITROS

Version/Model Number

6800368

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K973517

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

0c4dd621-7416-4293-99a3-609aa7045b9e

Public Version Date

April 16, 2020

Public Version Number

1

DI Record Publish Date

April 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-