FDA.reportPublic FDA data

Elecsys FSH

Primary DI
07613336217801
Brand
Elecsys FSH
Company
Roche Diagnostics GmbH
Model
09745840190
Catalog number
09745840190
Published
2024-08-19
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
CGJRADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGJRadioimmunoassay, Follicle-Stimulating HormoneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964693000ELECSYS FSH ASSAYBoehringer Mannheim Corp.1996-12-16CGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336217801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336217801076133362178017613336217801

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) 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
Primary DIBrandModelCatalogPublished
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
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026705 AccuDiag™ FSH ELISADiagnostic Automation, Inc.CGJ2026-01-27
14562185400318CL AIA-PACK FSH TEST CUPTOSOH CORPORATIONCGJ2025-09-01
04562185400311CL AIA-PACK FSH TEST CUPTOSOH CORPORATIONCGJ2025-09-01
04048474012880FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2024-11-22
04048474053555FSHDRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-09-01
04048474040982FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-08-31
00840239053558FSHDRG International IncCGJ2023-08-26
00840239012883FSH ELISADRG International IncCGJ2023-08-22
15099590575236Access hFSHBeckman Coulter, Inc.CGJ2023-06-26
B261CANFSH40600DBC Follicle Stimulating Hormone (FSH) ELISADiagnostics Biochem Canada IncCGJ2022-11-15
06925912718499iFlash-FSHShenzhen YHLO Biotech Co., Ltd.CGJ2022-10-26
B512210011One Step Menopausal TestUNIVERSAL MEDITECH INC.CGJ2021-10-15
07613336170373Elecsys FSHRoche Diagnostics GmbHCGJ2021-10-06
07613336170380Elecsys FSHRoche Diagnostics GmbHCGJ2021-10-06
15099590575250Access hFSH CalibratorsBeckman Coulter, Inc.CGJ2021-09-03
00404847412888FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2021-06-07
00840239040985FSH ELISADRG International IncCGJ2021-06-07
B24211FSHHUE010Follicle Stimulating Hormone (FSH) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGJ2020-09-25
00630414126210ADVIA Centaur® FSH MCMSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414167435IMMULITE 2000 FSH Kit Domestic 200TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414167442IMMULITE 2000 FSH Kit Domestic 600TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414177243ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414177250ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414204666ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414599045Atellica IM FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414599052Atellica IM FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414599069Atellica IM FSH MCMSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414953779IMMULITE®/IMMULITE® 1000 Systems FSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414953786IMMULITE® 2000 Systems FSH FSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414961507IMMULITE® 2000 Systems FSHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24