cobas® TaqScreen MPX Test - Roche Molecular Systems, Inc.

Duns Number:071674100

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More Product Details

Catalog Number

04584252190

Brand Name

cobas® TaqScreen MPX Test

Version/Model Number

04584252190

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

a23facf3-3cdb-4e77-b8ce-775a9d50b1d0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2014

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