FDA.reportPublic FDA data

VERSANT® HCV RNA 3.0 ASSAY bDNA

Primary DI
00630414472386
Brand
VERSANT® HCV RNA 3.0 ASSAY bDNA
Company
Siemens Healthcare Diagnostics Inc.
Model
10333499
Catalog number
2553870
Device description
HCV RNA 3.0 Assay (bDNA) US IVD (Box 1)
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZPAssay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414472386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414472386006304144723866304144723860630414472386

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-229-3711x@x.x
+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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050860Alinity mABBOTT MOLECULAR INC.MZP2023-08-18
00875197006391cobas® HCVRoche Molecular Systems, Inc.MZP2021-12-10
00884999047761Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047822Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999047839Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999048652Alinity mABBOTT MOLECULAR INC.MZP2020-05-04
00884999037472RealTimeABBOTT MOLECULAR INC.MZP2017-12-15
04015630935390cobas 8800 SystemRoche Diagnostics GmbHMZP2017-04-20
04015630935406cobas 6800 SystemRoche Diagnostics GmbHMZP2017-04-20
15420045506787Aptima®Hologic, Inc.MZP2017-03-08
15420045506794Aptima®Hologic, Inc.MZP2017-03-08
15420045506800Aptima®Hologic, Inc.MZP2017-03-08
00884999042681RealTimeABBOTT MOLECULAR INC.MZP2016-07-28
00875197004472cobas omni Wash Reagent WASH)Roche Diagnostics GmbHMZP2015-12-04
00875197004489cobas omni Specimen Diluent SPEC DIL)Roche Diagnostics GmbHMZP2015-12-04
00875197004496cobas omni Lysis Reagent LYS)Roche Diagnostics GmbHMZP2015-12-04
00875197004502cobas omni MGP Reagent MGP)Roche Diagnostics GmbHMZP2015-12-04
00875197004694cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMZP2015-12-04
00875197004748cobas® HBV/HCV/HIV-1 Control KitRoche Diagnostics GmbHMZP2015-12-04
00875197005127cobas® NHP Negative Control KitRoche Diagnostics GmbHMZP2015-12-04
00884999000698RealTimeABBOTT MOLECULAR INC.MZP2014-12-01
00884999000704RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000711RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999000728RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037434RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00884999037656RealTimeABBOTT MOLECULAR INC.MZP2014-11-20
00630414472393VERSANT® HCV RNA 3.0 ASSAY bDNASiemens Healthcare Diagnostics Inc.MZP2014-09-24
00875197004182COBAS® TaqMan® HCV Test For Use With the High Pure SystemRoche Molecular Systems, Inc.MZP2014-09-10
00875197001983COBAS® AmpliPrep/ COBAS® TaqMan® HCV TestRoche Molecular Systems, Inc.MZP2014-09-09
00875197003611COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0Roche Molecular Systems, Inc.MZP2014-09-09