FDA.reportPublic FDA data

Atellica IM aHCV 200T

Primary DI
00630414301341
Brand
Atellica IM aHCV 200T
Company
Siemens Healthcare Diagnostics Inc.
Model
11207260
Catalog number
11207260
Device description
Atellica IM aHCV 200T Kit
Published
2021-01-15
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
00630414301341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414301341006304143013416304143013410630414301341

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
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
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00380740199272AlinityAbbott GmbHMZO2026-09-04
00380740208899AlinityAbbott GmbHMZO2026-09-04
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
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
00630414597867Atellica™ IM aHCVSiemens Healthcare Diagnostics Inc.MZO2018-10-16
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