Primary Device ID | 00811727011497 |
NIH Device Record Key | d707eb09-9c56-44b7-a716-048bad42481b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pointe Scientific, Inc. |
Version Model Number | H7506-6 |
Catalog Number | H7506-6 |
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 | 00811727011497 [Primary] |
JPK | Mixture, Hematology Quality Control |
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 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POINTE SCIENTIFIC, INC. 78656241 3185944 Dead/Cancelled |
Pointe Scientific, Inc. 2005-06-22 |