Catalog Number

09D9622

Brand Name

ARCHITECT

Version/Model Number

9D96-22

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

42f8bef0-5c68-4f70-9470-5e861782b4a7

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-