Catalog Number

07682913001

Brand Name

cobas e 801 Immunoassay Analyzer

Version/Model Number

07682913001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2019

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

K162606

Product Code

JJE

Product Code Name

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Public Device Record Key

e006eec2-6188-4dad-8fff-807a234052b0

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

March 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-