femometer

Primary DI
06972412612017
Brand
femometer
Company
Hangzhou Laihe Biotech Co.,Ltd.
Model
FM-IVY-104
Device description
This product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.
Published
2024-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972412612017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972412612017069724126120176972412612017

GMDN Terms#

Term, Definition table
TermDefinition
Follicle stimulating hormone (FSH) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543330912
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972412618897LYHERDOA-765DOA-7652026-05-06
06972412611966LyherDTH-1012024-11-12
06972412618569LyherDOA-1012024-11-12
06972412619696LyherDTH-1022024-11-12
06972412619405Lyher3030022024-11-11
06972412612000 femometerFM-IVY-1042024-04-25
06972412611836 femometerFM-IVY-1032023-05-29
06972412611843 femometerFM-IVY-1032023-05-29