FDA.reportPublic FDA data

Atellica™ IM aHCV

Primary DI
00630414597867
Brand
Atellica™ IM aHCV
Company
Siemens Healthcare Diagnostics Inc.
Model
10995456
Catalog number
10995456
Device description
HCV (aHCV) - Atellica IM - RGT - 200T
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZOASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030056002
P030056003
P030056004
P030056005
P030056006
P030056007
P030056008
P030056009
P030056010
P030056011
P030056013

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030056002ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056003ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056004ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056005ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056006ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056007ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056008ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056009ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056010ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056011ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO
P030056013ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-12-22MZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597867006304145978676304145978670630414597867

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus total antibody IVD, kit, chemiluminescent assayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

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
HCT/P
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740208905AlinityAbbott GmbHMZO2026-09-04
07613336217092Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2025-10-27
07613336166956Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
07613336166970Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
07613336166994Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
00630414301341Atellica IM aHCV 200TSiemens Healthcare Diagnostics Inc.MZO2021-01-15
00380740130633AlinityAbbott GmbHMZO2019-10-11
00380740130640AlinityAbbott GmbHMZO2019-10-11
00380740130657AlinityAbbott GmbHMZO2019-10-11
00630414278742Atellica IM aHCV 200TSiemens Healthcare Diagnostics Inc.MZO2018-11-01
00630414278759ADVIA Centaur HCVSiemens Healthcare Diagnostics Inc.MZO2018-11-01
00630414597874Atellica™ IM aHCV QCSiemens Healthcare Diagnostics Inc.MZO2018-10-16
04015630939947Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-12-18
07613336154304Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-10-03
07613336154311Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-10-03
07613336154328PreciControl Anti-HCVRoche Diagnostics GmbHMZO2017-10-03
04015630936663Elecsys AntiHCV II immunoassayRoche Diagnostics GmbHMZO2015-09-21
04015630936670Elecsys AntiHCV II immunoassayRoche Diagnostics GmbHMZO2015-09-21
M769HCV271Hepatitis C CheckHome Access Health CorporationMZO2015-09-03
04015630919277Elecsys PreciControl Anti-HCVRoche Diagnostics GmbHMZO2014-12-18
00380740001391ARCHITECTAbbott GmbHMZO2014-11-18
00380740001407ARCHITECTAbbott GmbHMZO2014-11-18
00380740001414ARCHITECTAbbott GmbHMZO2014-11-18
00380740001421ARCHITECTAbbott GmbHMZO2014-11-18
10758750001095VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-24
10758750001101VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-22
10758750002801VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-22