FDA.reportPublic FDA data

VITROS

Primary DI
10758750001323
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6801758
Catalog number
6801758
Device description
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
Published
2016-08-26
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
MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750001320PackageGS130In Commercial Distribution
10758750001323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000132020758750001320
1075875000132310758750001323

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
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
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
14560189212081ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
04560189210172ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
07613336218334Elecsys CA 15-3 IIRoche Diagnostics GmbHMOI2024-07-30
00630414293479Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414293486Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414293509Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294049Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294056Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294063Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2020-05-31
00816870020495Monobind AccuBind CA 15-3 ELISA Kit - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870020501CA 15-3 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MOI2019-02-11
00816870022178CA 15-3 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870022185CA 15-3 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MOI2019-02-11
00380740145316ARCHITECTAbbott GmbHMOI2019-01-21
00380740145323ARCHITECTAbbott GmbHMOI2019-01-21
00380740145330ARCHITECTAbbott GmbHMOI2019-01-21
00380740131432AlinityAbbott GmbHMOI2018-12-31
00380740131449AlinityAbbott GmbHMOI2018-12-31
04015630939961Elecsys CA 15-3 IIRoche Diagnostics GmbHMOI2018-03-15
00630414598055Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598123Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598130Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598154Atellica IM CA 15-3 MCMSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598048Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598062Atellica IM BR MCMSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598079Atellica IM BR PRESiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598147Atellica IM CA 15-3® CalibratorSiemens Healthcare Diagnostics Inc.MOI2017-12-22
00630414598420Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2017-12-22
04251269200144Pin Type Socket WrenchNoras MRI products GmbHMOI2017-09-13
04251269200595Head Holder FlexibilityNoras MRI products GmbHMOI2017-09-06