FDA.reportPublic FDA data

Elecsys AFP

Primary DI
07613336172025
Brand
Elecsys AFP
Company
Roche Diagnostics GmbH
Model
09015124190
Catalog number
09015124190
Published
2022-12-07
Public version status
New
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
K220176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220176000Elecsys AFPRoche Diagnostics2022-09-15LOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336172025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336172025076133361720257613336172025

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217146Elecsys AFPRoche Diagnostics GmbHLOJ2024-10-22
07613336206157Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
07613336206164Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
10758750034819VITROSORTHO CLINICAL DIAGNOSTICSLOJ2022-10-24
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