Catalog Number

10053-10

Brand Name

Immunalysis Corporation

Version/Model Number

10053-10

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DKB

Product Code Name

Calibrators, Drug Mixture

Public Device Record Key

2d0970ef-e05f-4d9a-b698-d16673285bea

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-