FDA.reportPublic FDA data

VERSANT

Primary DI
00630414000534
Brand
VERSANT
Company
Siemens Healthcare Diagnostics Inc.
Model
10492006
Catalog number
10492006
Device description
LiPAScan software
Published
2017-09-15
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
00630414000534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414000534006304140005346304140005340630414000534

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

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
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
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