Pointe Scientific, Inc. HI990-REF
GUDID 00811727012838
ISE Internal Reference, for the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison’s disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Size: 5 x 600mL
POINTE SCIENTIFIC, INC.
Ion selective electrode (ISE) reference solution IVD, reagent| Primary Device ID | 00811727012838 |
| NIH Device Record Key | 6122ee8e-641b-47ae-baa0-505ac29a6765 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe Scientific, Inc. |
| Version Model Number | HI990-REF |
| Catalog Number | HI990-REF |
| 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 |
Customer Support Contacts
| Phone | 800-445-9853 |
| techservice@medtest.com | |
| Phone | 800-445-9853 |
| techservice@medtest.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727012838 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051646
FDA Product Code
| JGS | Electrode, Ion Specific, Sodium |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [Pointe Scientific, Inc.]
| 00811727014634 | Albumin Reagent, for the quantitative determination of Albumin in serum. Size: 1 x 2L |
| 00811727014627 | Albumin Reagent, for the quantitative determination of Albumin in serum. Size: 14 x 100mL |
| 00811727014610 | AST Reagent, for the quantitative determination of Aspartate Aminotransferase (AST) in human ser |
| 00811727014603 | ALT Reagent, for the quantitative determination of Alanine Aminotransferase in serum. Size: 1 x |
| 00811727014597 | Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in huma |
| 00811727014580 | Homocysteine Control Kit, is intended to be used as an assayed quality control serum when used f |
| 00811727014573 | Liquid Stable 2-Part Homocysteine Reagent, intended for in vitro quantitative determination of t |
| 00811727014566 | Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human |
| 00811727014559 | Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibrating results in |
| 00811727014542 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl |
| 00811727014535 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl |
| 00811727014528 | Hemoglobin Reagent, for the quantitative determination of Hemoglobin in whole blood. Size: 1 x 5 |
| 00811727014511 | Glucose-6-Phosphate Dehydrogenase (G6PD) Lyse. Size: 1 x 100 mL |
| 00811727014498 | Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in seru |
| 00811727014481 | Creatinine Enzymatic Reagent, for the quantitative enzymatic determination of creatinine in seru |
| 00811727014474 | Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and ur |
| 00811727014467 | Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagn |
| 00811727014450 | Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagn |
| 00811727014443 | Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or |
| 00811727014436 | Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or |
| 00811727014429 | Triglycerides Reagent, for the in vitro quantitative determination of Triglycerides in serum or |
| 00811727014405 | Total Protein Standard, intended for use as an total protein standard for standardization or cal |
| 00811727014399 | Total Protein Reagent, for the quantitative determination of total protein concentration in seru |
| 00811727014382 | Total Protein Reagent, for the quantitative determination of total protein concentration in seru |
| 00811727014375 | Phosphorus Standard, intended for use as an phosphorus standard for standardization or calibrati |
| 00811727014368 | Phosphorus Reagent, for the quantitative determination of Inorganic Phosphorus in serum. Size: 1 |
| 00811727014351 | Phosphorus Reagent, for the quantitative determination of Inorganic Phosphorus in serum. Size: 1 |
| 00811727014344 | Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l |
| 00811727014337 | Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l |
| 00811727014320 | Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l |
| 00811727014313 | Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of l |
| 00811727014306 | HDL Cholesterol Standard, for use as a cholesterol standard for standardization or calibration o |
| 00811727014290 | HDL Reagent, for the quantitative determination of High Density Lipoprotein (HDL) in Cholesterol |
| 00811727014283 | GGT Reagent, for the quantitative kinetic determination of gamma glutamyl transferase (GGT) acti |
| 00811727014276 | γ-Glutamyl Transferase Reagent, For the quantitative kinetic determination of gamma glutamyl tr |
| 00811727014269 | γ-Glutamyl Transferase (GGT) Reagent, for the quantitative kinetic determination of gamma gluta |
| 00811727014146 | For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accurac |
| 00811727014122 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014115 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014108 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014092 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014085 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014078 | Reagent for the quantitative determination of creatinine in serum. For in vitro diagnostic use |
| 00811727014061 | Reagent for the quantitative determination of Calcium in serum or heparinized plasma. 1 x 500 ml |
| 00811727014054 | Reagent for the quantitative determination of Calcium in serum or heparinized plasma. 1 x 120 ml |
| 00811727014047 | For the quantitative determination of creatine kinase activity in serum. 1 x 30 ml |
| 00811727014030 | Reagent for the quantitative determination of creatine kinase activity in serum. 1 x 120 ml |
| 00811727014023 | Reagent intended for use as an creatinine standard for standardization or calibration of modifie |
| 00811727014016 | Reagent for the quantitative determination of Total Cholesterol in serum. 1 x 500 ml |
| 00811727014009 | Reagent for the quantitative determination of Total Cholesterol in serum. 1 x 120 ml |
Trademark Results [Pointe Scientific, Inc.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POINTE SCIENTIFIC, INC. 78656241 3185944 Dead/Cancelled |
Pointe Scientific, Inc. 2005-06-22 |
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