FDA.reportPublic FDA data

Atellica IM aHCV 200T

Primary DI
00630414278742
Brand
Atellica IM aHCV 200T
Company
Siemens Healthcare Diagnostics Inc.
Model
11203473
Catalog number
11203473
Device description
Atellica IM aHCV 200T Kit
Published
2018-11-01
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
00630414278742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414278742006304142787426304142787420630414278742

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
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
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

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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
00630414278759ADVIA Centaur HCVSiemens Healthcare Diagnostics Inc.MZO2018-11-01
00630414597867Atellica™ IM aHCVSiemens Healthcare Diagnostics Inc.MZO2018-10-16
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04015630939947Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-12-18
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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
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