FSH HYE-5355

GUDID 04048474053555

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.

DRG Instruments Gesellschaft mit beschränkter Haftung

Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474053555
NIH Device Record Key01652778-2aed-45d3-bf39-3d5c2122f067
Commercial Distribution StatusIn Commercial Distribution
Brand NameFSH
Version Model NumberHYE-5355
Catalog NumberHYE-5355
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104048474053555 [Primary]

FDA Product Code

CGJRadioimmunoassay, Follicle-Stimulating Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

On-Brand Devices [FSH]

00404847453553The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurem
04048474053555The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurem

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.