| Primary Device ID | 00850035206393 | 
| NIH Device Record Key | 1ac69649-a221-48bc-9c70-aa40131c5503 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Proov | 
| Version Model Number | MFB-MH-10 | 
| 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 | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850035206393 [Primary] | 
| QKE | Immunoassay, Pregnanediol Glucuronide, Over The Counter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-08-25 | 
| Device Publish Date | 2025-08-15 | 
| 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 | 
| 00850035206393 | Multi-Hormone Test Strips for home use, testing PDG, E1G and LH | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  PROOV  87886242  5622245 Live/Registered | MFB Fertility, Inc. 2018-04-20 | 
|  PROOV  87126460  5160575 Live/Registered | Proov Systems Ltd. 2016-08-03 | 
|  PROOV  87126455  5160574 Live/Registered | Proov Systems Ltd. 2016-08-03 | 
|  PROOV  87126441  not registered Dead/Abandoned | Proov Systems Ltd. 2016-08-03 |