FDA.reportPublic FDA data

Atellica IM aHAVM QC

Primary DI
00630414597744
Brand
Atellica IM aHAVM QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995445
Catalog number
10995445
Device description
HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
Published
2017-12-27
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
LOLHepatitis a test (antibody and igm antibody)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOLHepatitis A Test (Antibody And Igm Antibody)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040018000ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALSBayer Healthcare, LLC2004-12-22LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597744006304145977446304145977440630414597744

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis A virus in a clinical specimen.

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
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
15099590806446Access anti-HAV IgMBeckman Coulter, Inc.LOL2026-04-23
00380740197650AlinityAbbott GmbHLOL2023-11-04
00630414301259Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00630414301297Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00380740136628AlinityAbbott GmbHLOL2020-12-23
00380740131371AlinityAbbott GmbHLOL2020-11-06
00380740131562AlinityAbbott GmbHLOL2020-01-06
00380740131579AlinityAbbott GmbHLOL2020-01-06
00380740136611AlinityAbbott GmbHLOL2020-01-06
07613336129715Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
07613336129722Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
00630414597737Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597775Atellica IM aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597768Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2017-12-22
04015630939855Elecsys Anti-HAV IgMRoche Diagnostics GmbHLOL2017-09-07
04015630939916Elecsys Anti-HAVRoche Diagnostics GmbHLOL2017-06-20
08056771100199LIAISON® anti-HAVDIASORIN SPALOL2016-09-24
08056771100205LIAISON® Control anti-HAVDIASORIN SPALOL2016-09-24
00630414479996ADVIA Centaur® HAV IgMSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414480008ADVIA Centaur® HAV IgM QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481876ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481883ADVIA Centaur® Systems QC aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414498461ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414509259ADVIA Centaur® aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
04015630938841Elecsys AntiHAV AssayRoche Diagnostics GmbHLOL2016-09-20
04015630938858Elecsys AntiHAV IgMRoche Diagnostics GmbHLOL2016-09-20
00847865012362MONOLISABIO-RADLOL2016-09-12
00847865012379MONOLISABIO-RADLOL2016-09-12
00380740011079ARCHITECTAbbott GmbHLOL2016-09-09
00380740011086ARCHITECTAbbott GmbHLOL2016-09-09