VERSANT HCV 2.0 LiPA 10492005

GUDID 00630414602882

HCV Genotype

Siemens Healthcare Diagnostics Inc.

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT) Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00630414602882
NIH Device Record Key9f2bd616-27b7-4509-915a-908467d54929
Commercial Distribution StatusIn Commercial Distribution
Brand NameVERSANT HCV 2.0 LiPA
Version Model Number10492005
Catalog Number10492005
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414602882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBFAssay, genotyping, hepatitis c virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-15

On-Brand Devices [VERSANT HCV 2.0 LiPA]

00630414602882HCV Genotype
00630414602875HCV genotype
00630414000503VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
00630414000497VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping

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