ADVIA Centaur® HBcT2 Quality Control Kit

Primary DI
00630414561233
Brand
ADVIA Centaur® HBcT2 Quality Control Kit
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10376699
Catalog number
10376699
Device description
ADVIA Centaur® HBcT2
Published
2023-06-20
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
SEIQualitative and Quantitative Hepatitis B Virus Antibody assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEIQualitative And Quantitative Hepatitis B Virus Antibody AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210019000ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)Siemens Healthcare Diagnostics, Inc.2022-07-27SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414561233PrimaryGS10
00630414210766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414561233006304145612336304145612330630414561233
00630414210766006304142107666304142107660630414210766

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core total 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 total antibodies to the Hepatitis B virus core antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, protect from light, do not freeze, and resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590806323Access anti-HBc IgM Beckman Coulter, Inc.SEI2026-05-04
15099590806330Access anti-HBc IgM CalibratorBeckman Coulter, Inc.SEI2026-05-04
15099590806347Access anti-HBc IgM QCBeckman Coulter, Inc.SEI2026-05-04
15099590806293Hepatitis B Virus core Total AntibodyBeckman Coulter, Inc.SEI2026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORBeckman Coulter, Inc.SEI2026-03-30
15099590806316ACCESS anti-HBc Total QCBeckman Coulter, Inc.SEI2026-03-30
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2024-04-26
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
00842768022678Atellica IM aHBe2Siemens Healthcare Diagnostics Inc.SEI2022-05-05
00630414167923ADVIA Centaur aHBe2 50T KitSiemens Healthcare Diagnostics Inc.SEI2022-01-14
00630414301266Atellica IM aHBcMSiemens Healthcare Diagnostics Inc.SEI2021-01-15
00630414301273Atellica IM aHBs2Siemens Healthcare Diagnostics Inc.SEI2021-01-15
00630414301303Atellica IM HBcTSiemens Healthcare Diagnostics Inc.SEI2021-01-15
00630414597799Atellica™ IM aHBcMSiemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414597805Atellica™ IM aHBcM QCSiemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414597836Atellica™ IM aHBs2Siemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414597843Atellica™ IM aHBs2 QCSiemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414599205Atellica™ IM HBcTSiemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414599212Atellica™ IM HBcT QCSiemens Healthcare Diagnostics Inc.SEI2018-10-16
00630414470498ADVIA Centaur® HBc IgMSiemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414470504ADVIA Centaur® Systems HBc IgM QCSiemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414498089ADVIA Centaur® Systems HBcT QCSiemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414498096ADVIA Centaur® HBcTSiemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414551777ADVIA Centaur® Systems aHBs2 QCSiemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414561790ADVIA Centaur® aHBs2Siemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414591407ADVIA Centaur® aHBs2Siemens Healthcare Diagnostics Inc.SEI2014-09-24
00630414970981IMMULITE® 2000 Systems aBC Anti-HBcSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2014-09-24