| Primary Device ID | 10810038633791 |
| NIH Device Record Key | 8ce3e6b2-3c6d-4a83-8371-1ee64d4a0f62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easy@Home Ovulation Test (100 LH strips+100 Cups) |
| Version Model Number | EZW2-S |
| Catalog Number | EZW-LH100C100 |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| Device Count | 100 |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038633794 [Primary] |
| GS1 | 10810038633791 [Package] Contains: 00810038633794 Package: Carton [20 Units] In Commercial Distribution |
| GS1 | 30810038633795 [Unit of Use] |
| NGE | Test, Luteinizing Hormone (Lh), 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 | 2023-04-20 |
| Device Publish Date | 2023-04-12 |
| 10810038636846 - Easy@Home Pregnancy Test (5 tests) | 2024-11-18 Easy@Home Pregnancy Test (5 tests) |
| 10810038636266 - Easy@Home Blood Pressure Monitor | 2024-11-12 |
| 10810038636990 - Areta Multi-Drug Test Cup (25 tests kit) | 2024-10-08 Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP |
| 10810038636549 - Easy@Home Pregnancy Test | 2024-10-04 Easy@Home Pregnancy Test |
| 40810038636434 - Easy@Home Multi-Drug Screen Test (5 tests kit) | 2024-07-25 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC |
| 20810038636447 - Easy@Home Nicotine Urine Test (5 tests one kit) | 2024-07-25 5 tests kit; Nicotine Urine Test -COT |
| 10810038636488 - Premom Smart Basal Thermometer | 2024-05-20 |
| 10810038636129 - Easy@Home Adhesive Electrode Pads | 2024-04-23 |