Catalog Number

42900109PST

Brand Name

QBC Diagnostics

Version/Model Number

42900109P

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K992849

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

165d2602-d85c-4f22-ad4c-caa5fadb472e

Public Version Date

January 24, 2019

Public Version Number

4

DI Record Publish Date

January 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-