Berichrom® Heparin LMW Control 1 - For use as a low level assayed control for the - Siemens Healthcare Diagnostics Products GmbH

Duns Number:388240673

Device Description: For use as a low level assayed control for the quantitative measurement of low molecular w For use as a low level assayed control for the quantitative measurement of low molecular weight heparin with Berichrom Heparin

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More Product Details

Catalog Number

OPCD03

Brand Name

Berichrom® Heparin LMW Control 1

Version/Model Number

10445990

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

K083159,K083159

Product Code Details

Product Code

GIZ

Product Code Name

PLASMA, CONTROL, NORMAL

Device Record Status

Public Device Record Key

ad73ae1d-d1ee-467a-b4a7-2ac9d0ed99cd

Public Version Date

September 05, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 101