| Primary Device ID | 00811727015013 |
| NIH Device Record Key | 3d7240f1-f22c-4896-9a22-e51a081ff7a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe Scientific, Inc. Creatinine |
| Version Model Number | OC939-739 |
| Catalog Number | OC939-739 |
| Company DUNS | 045623154 |
| Company Name | POINTE SCIENTIFIC, INC. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | 800-445-9853 |
| techservice@medtest.com | |
| Phone | 800-445-9853 |
| techservice@medtest.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727015013 [Primary] |
| CGX | Alkaline Picrate, Colorimetry, Creatinine |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
| 00811727015013 | Pointe Scientific, Inc. Creatinine Reagent is for the quantitative determination of creatinine i |
| 00811727014702 | Creatinine Reagent, for the quantitative determination of creatinine in serum. For in vitro dia |
| 00811727012982 | Creatinine Reagent is for the quantitative determination of creatinine in serum on Hitachi analy |