cobas Liat Software v3.1.1 Update Key for cobas Liat Analyzer - Roche Molecular Systems, Inc.

Duns Number:071674100

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More Product Details

Catalog Number

08415129001

Brand Name

cobas Liat Software v3.1.1 Update Key for cobas Liat Analyzer

Version/Model Number

08415129001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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 Details

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Device Record Status

Public Device Record Key

e344346d-8445-435d-afc6-bab1f44f426e

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

November 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ROCHE MOLECULAR SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 41
2 A medical device with a moderate to high risk that requires special controls. 48
3 A medical device with high risk that requires premarket approval 29