Proov

GUDID 00850035206164

A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains 3 FSH urine tests to check ovarian reserve, 10 LH tests to predict ovulation during the fertile window, 5 PdG tests to confirm ovulation during the implantation window, 2 hCG urine tests to aid in early detection of pregnancy.

Mfb Fertility, Inc.

Natural conception assistance kit

• Primary Device ID: 00850035206164
• NIH Device Record Key: 8a4df408-b0ab-493a-8a7e-be2ed1daf0ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proov
• Version Model Number: Fertility 4-in-1 Test
• Company DUNS: 080270263
• Company Name: Mfb Fertility, Inc.
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035206164 [Primary]

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

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: 2023-05-25
• Device Publish Date: 2023-05-17

On-Brand Devices [Proov]

• 00860002790817: Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulati
• 00850035206003: One Step Home Use Pregnancy Test Strip
• 00850035206126: At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.
• 00850035206102: At home IVD LH tests (also called ovulation tests or OPKs) measure luteinizing hormone before ov
• 00850035206058: At home IVD FSH test to measure follicle stimulating hormone and check your ovarian reserve stat
• 00850035206065: A comprehensive at home fertility test that measures four key hormones that impact your cycle an
• 00850035206164: A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains
• 00850035206157: A comprehensive screening kit that analyzes key hormone factors related to fertility. Contains