cobas Liat System Software v3.1 Update Key for cobas Liat Analyzer - Roche Molecular Systems, Inc.

Duns Number:071674100

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More Product Details

Catalog Number

08153248001

Brand Name

cobas Liat System Software v3.1 Update Key for cobas Liat Analyzer

Version/Model Number

08153248001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 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

a767b0aa-eafc-41e4-9bbb-a9e2806b4cd3

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

July 15, 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