VERSANT HCV 2.0 LiPA - VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test - Siemens Healthcare Diagnostics Inc.

Duns Number:064608573

Device Description: VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping

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More Product Details

Catalog Number

10719667

Brand Name

VERSANT HCV 2.0 LiPA

Version/Model Number

10719667

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P160016

Product Code Details

Product Code

OBF

Product Code Name

Assay, genotyping, hepatitis c virus

Device Record Status

Public Device Record Key

47577d72-b851-4bad-87c0-b3dc710fc0c9

Public Version Date

November 19, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7