Catalog Number

6192255

Brand Name

VITROS

Version/Model Number

6192255

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

K201312

Product Code

NBC

Product Code Name

Test, natriuretic peptide

Public Device Record Key

abe48ae4-c59b-49fd-935a-88e71e53e73b

Public Version Date

November 16, 2021

Public Version Number

1

DI Record Publish Date

November 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-