VERSANT HCV 2.0 LiPA

Primary DI
00630414000497
Brand
VERSANT HCV 2.0 LiPA
Company
Siemens Healthcare Diagnostics Inc.
Model
10719666
Catalog number
10719666
Device description
VERSANT HCV Amplification 2.0 Kit (LiPA) 40 Test for HCV genotyping
Published
2017-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBFAssay, genotyping, hepatitis c virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBFAssay, Genotyping, Hepatitis C VirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414000497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414000497006304140004976304140004970630414000497

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
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00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
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00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414470156870LiRAS for LiPA HCV v1Fujirebio EuropeOBF2025-05-30
05414470816590INNO-LiPA HCV 2.0 GenotypingFujirebio EuropeOBF2025-05-30
05414470816606INNO-LiPA HCV 2.0 AmpFujirebio EuropeOBF2025-05-30
05414470816613INNO-LiPA HCV 2.0 ControlFujirebio EuropeOBF2025-05-30
05414470816620INNO-LiPA HCV 2.0 GenotypingFujirebio EuropeOBF2025-05-30
05414470816637INNO-LiPA HCV 2.0 AmpFujirebio EuropeOBF2025-05-30
00884999037472RealTimeABBOTT MOLECULAR INC.OBF2017-12-15
00630414000503VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)Siemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414000534VERSANTSiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414602875VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00630414602882VERSANT HCV 2.0 LiPASiemens Healthcare Diagnostics Inc.OBF2017-09-15
00884999042513RealTimeABBOTT MOLECULAR INC.OBF2016-09-01
00884999034266RealTimeABBOTT MOLECULAR INC.OBF2014-11-20
00884999036130RealTimeABBOTT MOLECULAR INC.OBF2014-11-20
00884999036147RealTimeABBOTT MOLECULAR INC.OBF2014-11-20
00884999036444RealTimeABBOTT MOLECULAR INC.OBF2014-11-20