| Primary Device ID | 00850253007000 |
| NIH Device Record Key | 8591f956-e474-432f-8479-627ee5e38c9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Areta Ketone Urinalysis Reagent Strips (100 tests kit） |
| Version Model Number | U031-013 |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850253007000 [Primary] |
| GS1 | 00850253007017 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 10850253007014 [Package] Contains: 00850253007017 Package: [50 Units] In Commercial Distribution |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-08-01 |