FDA.reportPublic FDA data

VITROS

Primary DI
10758750001224
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6801429
Catalog number
6801429
Device description
VITROS Immunodiagnostic Products Anti-HBc Calibrator
Published
2014-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030024021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030024021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOROrtho-Clinical Diagnostics2004-03-04SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750001221PackageGS130In Commercial Distribution
10758750001224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000122120758750001221
1075875000122410758750001224

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core 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 B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336160367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-10-02
07613336230367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-08-20
00380740160579AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740160593AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740161262AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214289AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214296AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214302AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2024-04-26
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00380740156992ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740157012ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740158187ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740163389ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208462ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208479ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208486ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740171742ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740171759ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740173555AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00380740173562AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00842768022678Atellica IM aHBe2Siemens Healthcare Diagnostics Inc.LOM2022-05-05
07613336203606Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336203613Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336175293Elecsys HBsAg Confirmatory TestRoche Diagnostics GmbHLOM2022-01-26
00630414167923ADVIA Centaur aHBe2 50T KitSiemens Healthcare Diagnostics Inc.LOM2022-01-14
04015630940134Elecsys Anti-HBeRoche Diagnostics GmbHLOM2021-12-09