FDA.reportPublic FDA data

FSH

Primary DI
00840239053558
Brand
FSH
Company
DRG International Inc
Model
HYE-5355
Catalog number
HYE-5355
Device description
The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of follicle stimulating hormone in serum, heparin-, and EDTA-plasma.
Published
2023-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840239053558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239053558008402390535588402390535580840239053558

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
1 973-564-7555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
07613336217801Elecsys FSHRoche Diagnostics GmbHCGJ2024-08-19
04048474053555FSHDRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-09-01
04048474040982FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-08-31
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