Pointe Scientific, Inc. HB752-510
GUDID 00811727013378
Reagent for the quantitative determination of urea nitrogen in serum on Hitachi analyzers. For in vitro diagnostic use only. 8 x 50ml, 2 x 55ml
POINTE SCIENTIFIC, INC.
Urea IVD, reagent| Primary Device ID | 00811727013378 |
| NIH Device Record Key | c85db713-a172-414e-8945-69e7a7532d82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pointe Scientific, Inc. |
| Version Model Number | HB752-510 |
| Catalog Number | HB752-510 |
| 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 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811727013378 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K972671
FDA Product Code
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.