FDA.reportPublic FDA data

VERSANT® HCV RNA 3.0 ASSAY bDNA

Primary DI
00630414472393
Brand
VERSANT® HCV RNA 3.0 ASSAY bDNA
Company
Siemens Healthcare Diagnostics Inc.
Model
10333501
Catalog number
2554338
Device description
HCV RNA 3.0 Assay (bDNA) US IVD (Box 2)
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
00630414472393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414472393006304144723936304144723930630414472393

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-80 Degrees Celsius-60 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
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
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
00630414472386VERSANT® 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