Catalog Number

09D9624

Brand Name

ARCHITECT

Version/Model Number

09D9624

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

CZW

Product Code Name

COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

2e4958f3-1ed3-4a27-b4f1-fbd8e7bc12f4

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-