FDA.reportPublic FDA data

AccuDiag™ FSH ELISA

Primary DI
00850054026705
Brand
AccuDiag™ FSH ELISA
Company
Diagnostic Automation, Inc.
Model
DACD4224-15
Catalog number
4224-15
Device description
AccuDiag™ FSH ELISA
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGJRadioimmunoassay, Follicle-Stimulating Hormone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054026705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054026705008500540267058500540267050850054026705

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, kit, radioimmunoassayA 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 radioimmunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8185913030onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
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
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24
00850082766000QMedix™DACD113030-1-19113030-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07613336217801Elecsys FSHRoche Diagnostics GmbHCGJ2024-08-19
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