FDA.reportPublic FDA data

VITROS

Primary DI
10758750034819
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6177745
Catalog number
6177745
Device description
VITROS Immunodiagnostic Products AFP Reagent Pack
Published
2022-10-24
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
LOJKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOJKit, Test,Alpha-Fetoprotein For Testicular CancerImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213626000VITROS AFPOrtho Clinical Diagnostics2022-06-15LOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750034816PackageGS130In Commercial Distribution
10758750034819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003481620758750034816
1075875003481910758750034819

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) 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
07613336217146Elecsys AFPRoche Diagnostics GmbHLOJ2024-10-22
07613336172025Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-07
07613336206157Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
07613336206164Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2020-05-31
00816870020426Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020433AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870020440AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870020457AFP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870020464AFP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020884AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020891AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870021843AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022109AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022116AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870022123AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870022130AFP AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022147Monobind AccuLite AFP CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022543Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022550AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870023281AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00630414598369Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2017-12-27
00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2017-12-27
04015630939909Elecsys AFPRoche Diagnostics GmbHLOJ2017-04-14
14560189210230ST AIA-PACK AFPTOSOH CORPORATIONLOJ2016-09-24
04560189211162AIA-PACK AFP Sample Diluting SolutionTOSOH CORPORATIONLOJ2016-09-24
00842768019937Dimension Vista® Flex® reagent cartridge AFPSiemens Healthcare Diagnostics Inc.LOJ2016-09-24
04015630920716Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
04015630938810Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
10758750000876VITROSORTHO CLINICAL DIAGNOSTICSLOJ2016-08-26