Catalog Number

CO3/1

Brand Name

Cand-Tec

Version/Model Number

CO3/1

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

-

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

-

FDA Premarket Submission

K823016

Product Code

LHK

Product Code Name

ANTIGEN, ID, CANDIDA ALBICANS

Public Device Record Key

fc5d67ea-868a-480f-ae24-f122cbcd0824

Public Version Date

April 03, 2019

Public Version Number

1

DI Record Publish Date

March 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-