Catalog Number

-

Brand Name

OLO CBC Test Kit

Version/Model Number

TK1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

29b0382c-198c-41cf-b455-c721404111f0

Public Version Date

January 27, 2022

Public Version Number

2

DI Record Publish Date

February 09, 2020

Package DI Number

B787TK11

Quantity per Package

25

Contains DI Package

B787TK10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-