FDA.reportPublic FDA data

LiRAS for LiPA HCV v1

Primary DI
05414470156870
Brand
LiRAS for LiPA HCV v1
Company
Fujirebio Europe
Model
15687
Published
2025-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05414470156870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414470156870054144701568705414470156870

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The production identifier of this product is the software identification

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+32093291329info@fujirebio.com

Regulatory Flags#

DUNS number
297346645
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414470816590INNO-LiPA HCV 2.0 Genotyping816592025-05-30
05414470816606INNO-LiPA HCV 2.0 Amp816602025-05-30
05414470816613INNO-LiPA HCV 2.0 Control816612025-05-30
05414470816620INNO-LiPA HCV 2.0 Genotyping816622025-05-30
05414470816637INNO-LiPA HCV 2.0 Amp816632025-05-30
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction Cartridges815502025-06-16
05414470815579Lumipulse G pTau 217 Plasma Calibrators815572025-06-16
05414470815586Lumipulse pTau 217 Plasma Controls815582025-06-16
05414470815593Lumipulse B-Amyloid Plasma Controls815592025-06-16
05414470804214TENDIGO Disposable TraysCat No. 804212022-09-14
05414470806287Auto-LiPA 48 806282020-02-24
05414470806294Auto-LIA 48806292020-02-24
05414470804122TENDIGO804122020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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