FDA.reportPublic FDA data

Elecsys Anti-HBc II

Primary DI
07613336246672
Brand
Elecsys Anti-HBc II
Company
Roche Diagnostics GmbH
Model
09745009160
Catalog number
09745009160
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K260046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260046000Elecsys Anti-HBc IIRoche Diagnostics2026-04-07SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336246672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336246672076133362466727613336246672

Regulatory Flags#

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336246436cobas ultra controller10856653001108566530012026-11-05
07613336217702Elecsys T309744975190097449751902026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

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
00630414561233ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDSEI2023-06-20
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