cobas Liat Cleaning Tool - Roche Molecular Systems, Inc.

Duns Number:071674100

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More Product Details

Catalog Number

07402759190

Brand Name

cobas Liat Cleaning Tool

Version/Model Number

07402759190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

9b3814c4-47ff-4f9c-bd8b-863697f29fce

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

February 22, 2018

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