Proov

GUDID 00860002790817

Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.

Mfb Fertility, Inc.

Natural conception assistance kit

• Primary Device ID: 00860002790817
• NIH Device Record Key: 9a556f73-b1a7-400f-8715-3f3529ccb1e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proov
• Version Model Number: Confirm
• 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	00860002790817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191462

FDA Product Code

• QKE: Immunoassay, Pregnanediol Glucuronide, 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: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [Proov]

• 00860002790817: Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulati
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