Catalog Number

01-2050-01

Brand Name

INFINITI® Factor II-V Leiden Intellipac® Reagent Module

Version/Model Number

01-2050-01

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

K060564

Product Code

NPQ

Product Code Name

TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR

Public Device Record Key

c34235e3-a428-4bfd-913c-f4ce4bb97fdd

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-