| Primary Device ID | 10810038634699 |
| NIH Device Record Key | 9fd6fc02-0191-49e9-9d25-01016dd97d75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One Step FSH Urine Test Strip(10 Tests) |
| Version Model Number | EFS1-S |
| Catalog Number | RH-FSH-S10 |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| Device Count | 10 |
| 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 | 00810038634692 [Primary] |
| GS1 | 10810038634699 [Package] Contains: 00810038634692 Package: Carton [250 Units] In Commercial Distribution |
| GS1 | 30810038634693 [Unit of Use] |
| NGA | Test, Follicle Stimulating Hormone (Fsh), 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 | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
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