Catalog Number

IVD-1-Chek

Brand Name

IBSchek

Version/Model Number

IVD-1-Chek

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

-

Product Code

PQD

Product Code Name

Blood Specimen Collection Convenience Kit (Excludes Hiv)

Public Device Record Key

af66be35-2b5e-4682-9b6a-592012fb7149

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

May 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-