| Primary Device ID | 00811727013774 |
| NIH Device Record Key | 49309693-b22f-49f9-ae9d-48359ce1b3c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALT R2 (w/ssa#) |
| Version Model Number | 13-A7526-R2-125 |
| Catalog Number | 13-A7526-R2-125 |
| 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 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727013774 [Primary] |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-31 |
| 00811727015709 - Pointe Alkaline Phosphatase on the BS480 | 2023-07-06 Pointe Alkaline Phosphatase packaged for the BS480 Analyzer. 3x60mL, 3x15mL kit. For the quantitative determination of alkaline |
| 00811727015723 - Pointe Amylase on BS480 Analyzer | 2023-07-06 Pointe Amylase packaged for use on the BS480 Analyzer. 6x20mL kit. For the quantitative kinetic determination of a-amylase activ |
| 00811727015730 - Pointe AST on the BS480 Analyzer | 2023-07-06 Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotran |
| 00811727015754 - Pointe Calcium Arsenazo for BS480 | 2023-07-06 Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or h |
| 00811727015778 - Pointe Cholesterol on BS480 | 2023-07-06 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in |
| 00811727015792 - Pointe Carbon Dioxide on the BS480 | 2023-07-06 Pointe Carbon Dioxide packaged for use on the BS480 analyzer. 4x40mL Kit. For the quantitative determination of Carbon Dioxide |
| 00811727015839 - Pointe GGT on BS480 | 2023-07-06 Pointe GGT Reagent packaged for use on the BS480. 4x40mL 4x10mL Kit. For the quantitative kinetic determination of gamma glutamy |
| 00811727015846 - Pointe Glucose Hexokinase for BS480 | 2023-07-06 Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of gluco |