| Primary Device ID | 00023513487441 |
| NIH Device Record Key | f544fa20-aa9a-45a7-9991-c53f6b64ef13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DG Health |
| Version Model Number | UTES |
| Company DUNS | 004172052 |
| Company Name | REESE PHARMACEUTICAL COMPANY |
| 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 | 00023513487441 [Primary] |
| LJX | Test, Urine Leukocyte |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2020-06-01 |
| 10023513132157 - Reese's ColoTest | 2024-05-06 |
| 10023513132140 - Reese's ColoTest | 2024-01-31 |
| 00023513487441 - DG Health | 2021-12-22OTC Single Use urinary test strip |
| 00023513487441 - DG Health | 2021-12-22 OTC Single Use urinary test strip |
| 00023513000039 - TopCare | 2020-08-24 OTC Single Use urinary test strip |