| Primary Device ID | 00811727011978 | 
| NIH Device Record Key | 6aceb6c3-3bfe-47a4-aa81-340fded11ad8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pointe Scientific, Inc. Phosphorus Std | 
| Version Model Number | P7516-STD | 
| Catalog Number | P7516-STD | 
| 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 | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| Phone | 800-445-9853 | 
| techservice@medtest.com | |
| 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 | 
| 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 | 00811727011978 [Primary] | 
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 
| 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 | 
| 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 |