Catalog Number

GXHEMOSIL-10

Brand Name

Xpert HemosIL FII & FV

Version/Model Number

GXHEMOSIL-10

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082118

Product Code

NPQ

Product Code Name

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Public Device Record Key

34b3903f-b556-4eeb-873d-3a4283b680bb

Public Version Date

May 03, 2022

Public Version Number

4

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-