femometer

GUDID 06972412612017

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.

Hangzhou Laihe Biotech Co.,Ltd.

Follicle stimulating hormone (FSH) IVD, reagent

• Primary Device ID: 06972412612017
• NIH Device Record Key: 08ef4d59-13a6-4948-a338-c1443cd85a2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: femometer
• Version Model Number: FM-IVY-104
• Company DUNS: 543330912
• Company Name: Hangzhou Laihe Biotech Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972412612017 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-03
• Device Publish Date: 2024-04-25

On-Brand Devices [ femometer]

• 06972412611843: Test for luteinizing hormone in urine to predict ovulation date, test sticks refill pack.
• 06972412611836: Test for luteinizing hormone in urine to predict ovulation date, including meter and test sticks
• 06972412612017: This product is a rapid, one-step, visual test for the qualitative detection of follicle stimula
• 06972412612000: This product is a rapid, one-step, visual test for the qualitative detection of follicle stimula