Catalog Number

997-43801

Brand Name

CH50 Calibrator

Version/Model Number

997-43801

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2020

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

K954145

Product Code

DAE

Product Code Name

Complement C9, Antigen, Antiserum, Control

Public Device Record Key

54c80851-f3d0-412e-abde-e0acfc7f7fa1

Public Version Date

October 26, 2020

Public Version Number

5

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-