| Primary Device ID | 00811727015839 |
| NIH Device Record Key | 921e606f-3696-4a03-ac9e-ac815975bf62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe GGT on BS480 |
| Version Model Number | 14-G7571-200 |
| Catalog Number | 14-G7571-200 |
| 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@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com | |
| Phone | 800-445-9853 |
| techservice@medtestdx.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 00811727015839 [Primary] |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2020-05-28 |
| 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 | 2023-07-06Pointe GGT Reagent packaged for use on the BS480. 4x40mL 4x10mL Kit. For the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. |
| 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 |