Catalog Number

07K6539

Brand Name

ARCHITECT

Version/Model Number

7K65-39

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

CEC

Product Code Name

RADIOIMMUNOASSAY, FREE THYROXINE

Public Device Record Key

3f84d61c-e394-46a6-bd89-47d8922fd97c

Public Version Date

June 14, 2018

Public Version Number

1

DI Record Publish Date

May 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-