| Primary Device ID | B512200011 |
| NIH Device Record Key | 90ec2937-b244-40af-bdb1-e108b8dccfb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One Step Ovulation Test |
| Version Model Number | 20001 |
| Catalog Number | 200-01 |
| Company DUNS | 080243910 |
| Company Name | UNIVERSAL MEDITECH INC. |
| Device Count | 1 |
| 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 |
|---|---|
| HIBCC | B512200011 [Primary] |
| 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 | 2021-10-25 |
| Device Publish Date | 2021-10-15 |
| B512100011 - One Step Pregnancy Test | 2021-10-25 |
| B512200011 - One Step Ovulation Test | 2021-10-25 |
| B512200011 - One Step Ovulation Test | 2021-10-25 |
| B512210011 - One Step Menopausal Test | 2021-10-25 |
| 00860002273006 - DoublecheQ Pregnancy Test | 2019-08-09 The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in |
| 00680243766491 - DoublecheQ Pregnancy Test | 2019-06-28 The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in |