Catalog Number

05412722001

Brand Name

cobas 8800 System

Version/Model Number

05412722001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MZP

Product Code Name

ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Public Device Record Key

e29fdb19-4555-40e5-9146-54e2513c284b

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

April 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-