RealTime - Abbott RealTime IDH1 Amplification Reagent Kit - ABBOTT MOLECULAR INC.

Duns Number:878263359

Device Description: Abbott RealTime IDH1 Amplification Reagent Kit

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More Product Details

Catalog Number

08N90-090

Brand Name

RealTime

Version/Model Number

08N90-090

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

Yes

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

OWD

Product Code Name

Somatic gene mutation detection system

Device Record Status

Public Device Record Key

44aaafb3-42bb-4ee5-92ba-e8f04ada69d5

Public Version Date

May 25, 2020

Public Version Number

3

DI Record Publish Date

July 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT MOLECULAR INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 339
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 36