Catalog Number

995-40801

Brand Name

Autokit CH50

Version/Model Number

995-40801

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

K954145,K954145

Product Code

DAE

Product Code Name

Complement C9, Antigen, Antiserum, Control

Public Device Record Key

60a53278-db88-417f-8161-35eec48af3fe

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

October 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-