Proov

Basic Information

• Brand Name: Proov
• Primary DI: 00850035206164
• Version / Model: Fertility 4-in-1 Test
• Company Name: Mfb Fertility, Inc.
• Labeler DUNS: 080270263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 1
• Public Version Date: 2023-05-25
• Public Version Status: New
• Public Device Record Key: 8a4df408-b0ab-493a-8a7e-be2ed1daf0ef

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	862.1155	2
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	862.1155	2
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Clinical Chemistry	862.1620	1
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	862.1485	1
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	862.1300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60862	Natural conception assistance kit	A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850035206164	GS1