Catalog Number

-

Brand Name

VisuLize Factor FVIII Antigen Kit

Version/Model Number

FVIII-AG

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052825,K052825

Product Code

GGP

Product Code Name

Test, Qualitative And Quantitative Factor Deficiency

Public Device Record Key

8ecc3de6-1c41-4f21-89a6-db5099740ed3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-