Catalog Number

07P6930

Brand Name

Alinity

Version/Model Number

07P6930

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

CDP

Product Code Name

RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Public Device Record Key

a0e8cd01-624e-4450-90d9-eb4bbd38e3a2

Public Version Date

January 26, 2021

Public Version Number

2

DI Record Publish Date

July 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-