Factor V Leiden 10873903

GUDID 00630414639758

Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect

Siemens Healthcare Diagnostics Products GmbH

Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting Activated protein C resistance ratio (APCR) IVD, kit, clotting
Primary Device ID00630414639758
NIH Device Record Key54ff22c9-5e08-4744-baf5-87dae78eb5f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFactor V Leiden
Version Model Number10873903
Catalog Number10873903
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414639758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGWTEST, TIME, PARTIAL THROMBOPLASTIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [Factor V Leiden]

00842768033520Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasm
00630414639758Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasm
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