RealTime - Abbott RealTime HCV m2000 System Combined - ABBOTT MOLECULAR INC.

Duns Number:878263359

Device Description: Abbott RealTime HCV m2000 System Combined Application CD-ROM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

04N45-004

Brand Name

RealTime

Version/Model Number

04N45-004

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

P100017,P100017,P100017,P100017,P100017

Product Code Details

Product Code

MZP

Product Code Name

ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Device Record Status

Public Device Record Key

45cc8484-fd04-453e-b353-ac153581cfba

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

July 28, 2016

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