femometer

GUDID 06972412611843

Test for luteinizing hormone in urine to predict ovulation date, test sticks refill pack.

Hangzhou Laihe Biotech Co.,Ltd.

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06972412611843
• NIH Device Record Key: ccf41aa3-d438-440e-98c1-75ee42c70898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: femometer
• Version Model Number: FM-IVY-103
• Company DUNS: 543330912
• Company Name: Hangzhou Laihe Biotech Co.,Ltd.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972412611843 [Primary]
GS1	06972412619443 [Unit of Use]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), Over The Counter

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: 2023-06-06
• Device Publish Date: 2023-05-29

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