FDA.reportPublic FDA data

Atellica IM aHAVT

Primary DI
00630414301297
Brand
Atellica IM aHAVT
Company
Siemens Healthcare Diagnostics Inc.
Model
11207271
Catalog number
11207271
Device description
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
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
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
K142758000
P040017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142758000ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.2014-12-05LOL
P040017000ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALSBayer Healthcare, Diagnostics Division2005-03-07LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414301297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414301297006304143012976304143012970630414301297

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis A 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
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
15099590806446Access anti-HAV IgMBeckman Coulter, Inc.LOL2026-04-23
00380740197650AlinityAbbott GmbHLOL2023-11-04
00630414301259Atellica IM aHAVMSiemens 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
00630414597744Atellica IM aHAVM QCSiemens 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