FDA.reportPublic FDA data

VERSANT HCV 2.0 LiPA

Primary DI
00630414000503
Brand
VERSANT HCV 2.0 LiPA
Company
Siemens Healthcare Diagnostics Inc.
Model
10719667
Catalog number
10719667
Device description
VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Published
2017-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160016000VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)Fujirebio Europe N.V.2017-03-14OBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414000503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414000503006304140005036304140005030630414000503

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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

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
00630414000497VERSANT 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