This page includes the latest FDA filings for Medtest Dx. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 1827821 |
| FEI Number | 1827821 |
| Name | MedTest Dx |
| Owner & Operator | MedTest Dx |
| Contact Address | 5449 RESEARCH DRIVE -- Canton MI 48188 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5449 RESEARCH DRIVE Canton Twp, MI 48188 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
MedTest Dx | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | 2020-03-12 |
MedTest Dx | Pointe 180 impulse Analyzer | 2019-11-18 |
MedTest Dx | Pointe 180 impulse Analyzer | 2019-11-18 |
MedTest Dx | Pointe 180 impulse Analyzer | 2019-11-18 |
MedTest Dx | Pointe 180 impulse Analyzer | 2019-11-18 |
MedTest Dx | BA-800M Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BA-800M Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BA-800M Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BA-800M Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BA-800M Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BS-480 Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BS-480 Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BS-480 Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BS-480 Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | BS-480 Automated Chemistry Analyzer | 2019-11-18 |
MedTest Dx | Pointe Scientific Lp(a) (L7597) | 2019-04-18 |
MedTest Dx | Pointe Scientific Lipoprotein (a) | 2019-04-18 |
MedTest Dx | Pointe Scientific Lipoprotein (a) Control (L7597-CTL) | 2019-04-18 |
MedTest Dx | Pointe Scientific Lipoprotein (a) Calibrator (L7597-CAL) | 2019-04-18 |
MedTest Dx | Pointe Scientific Lipoprotein (a) Control (L7597-CTL) | 2019-04-18 |
MedTest Dx | Pointe Scientific Lipoprotein (a) Calibrator (L7597-CAL) | 2019-04-18 |
MedTest Dx | MedTest DX C-Reactive Protein, CRP, CRP-HS, CRP Calibrator (CRP480, CRP600, CRP800, CRPC480) | 2018-05-14 |
MedTest Dx | C-Reactive Protein, CRP Calibrator, CRP Standard (C7568, C7568-CAL, C7568-STD) | 2018-05-14 |
MedTest Dx | C-Reactive Protein Reagent | 2018-05-14 |
MedTest Dx | MedTest DX Direct HDL/LDL Cholesterol Calibrator | 2016-12-02 |
MedTest Dx | MedTest DX Lactate, MedTest DX Lactate Standard | 2016-09-26 |
MedTest Dx | Lactate | 2016-09-26 |
MedTest Dx | Lactate Standard | 2016-09-26 |
MedTest Dx | MedTest DX Calibration Serum Level 2 | 2016-09-26 |
MedTest Dx | MedTest DX Reconstitution Fluid | 2016-09-26 |
MedTest Dx | MedTest DX Assayed Human Multi Sera Controls (Level 1 and Level 2) | 2016-09-26 |
MedTest Dx | MedTest DX Elevated HCG Controls (Level A & Level B) | 2016-09-26 |
MedTest Dx | MedTest DX Calibration Serum Level 1 | 2016-09-26 |
MedTest Dx | MedTest DX Fructosamine | 2016-09-26 |
MedTest Dx | MedTest DX Fructosamine Controls | 2016-09-26 |
MedTest Dx | MedTest DX Fructosamine Calibrators | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) Calibrators | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) Calibrators | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) | 2016-09-26 |
MedTest Dx | MedTest DX Lipoprotein (a) Calibrators | 2016-09-26 |
MedTest Dx | 3-H7590-R1 HDL-C R1 and 3-H7590-R2 HDL-C R2 | 2016-09-08 |
MedTest Dx | 3003 Direct Lipid Control L3 | 2016-08-18 |
MedTest Dx | 3002 Direct Lipid Control L2 | 2016-08-18 |
MedTest Dx | 3001 Direct Lipid Control L1 | 2016-08-18 |
MedTest Dx | 3000 Direct Lipid Control Set | 2016-08-18 |
MedTest Dx | MedTest DX Lipid Control Set | 2016-07-21 |
MedTest Dx | Lipid Control Set | 2016-07-21 |
MedTest Dx | S1113 Progesterone | 2016-07-21 |
MedTest Dx | S1111 Estradiol | 2016-07-21 |
MedTest Dx | S1887 Cortisol | 2016-07-21 |
MedTest Dx | MedTest DX Homocysteine Controls | 2016-05-03 |
MedTest Dx | Homocysteine Controls | 2016-05-03 |
MedTest Dx | MedTest DX Homocysteine Controls | 2016-05-03 |
MedTest Dx | Homocysteine Controls | 2016-05-03 |
MedTest Dx | MedTest DX Homocysteine Controls | 2016-05-03 |
MedTest Dx | Homocysteine Controls | 2016-05-03 |
MedTest Dx | MedTest DX Homocysteine | 2016-05-03 |
MedTest Dx | Homocysteine Calibrator | 2016-05-03 |
MedTest Dx | HOMOCYSTEINE | 2016-05-03 |
MedTest Dx | MedTest DX Homocysteine | 2016-05-03 |
MedTest Dx | Homocysteine Calibrator | 2016-05-03 |
MedTest Dx | HOMOCYSTEINE | 2016-05-03 |
MedTest Dx | c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | Mindray BS-200 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | Mindray BS-200 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | Mindray BS-200 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | Mindray BS-200 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | Mindray BS-200 Chemistry Analyzer | 2015-11-19 |
MedTest Dx | MedTest DX Chemistry Controls | 2015-10-28 |
MedTest Dx | Chemistry Controls | 2015-10-28 |
MedTest Dx | Random Access Fluid | 2014-12-08 |
MedTest Dx | F1029 FSH | 2014-12-08 |
MedTest Dx | F1037 Prolactin | 2014-12-08 |
MedTest Dx | F1031 LH | 2014-12-08 |
MedTest Dx | Triglyceride Std | 2014-12-05 |
MedTest Dx | T8006 CMV IgM | 2014-12-02 |
MedTest Dx | T8004 Rubella IgM | 2014-12-02 |
MedTest Dx | T8002 Toxoplasma IgM | 2014-12-02 |
MedTest Dx | T8007 HSV IgG | 2014-12-02 |
MedTest Dx | T8003 Rubella IgG | 2014-12-02 |
MedTest Dx | T8001 Toxoplasma IgG | 2014-12-02 |
MedTest Dx | T8005 CMV IgG | 2014-12-02 |
MedTest Dx | CO2 Standard | 2014-09-12 |
MedTest Dx | MedTest DX Hemoglobin A1c Controls (HBAQ400, HBAQ480) | 2014-09-10 |
MedTest Dx | Hemoglobin A1c Controls (H7546-CTL) | 2014-09-10 |
MedTest Dx | MedTest DX Creatinine (Enzymatic) | 2011-11-17 |
MedTest Dx | CREATININE (ENZYMATIC) | 2011-11-17 |
MedTest Dx | MedTest DX Glucose Hexokinase | 2010-11-23 |
MedTest Dx | Liquid Stable Glucose Hexokinase | 2010-11-23 |
MedTest Dx | IgE P1035 | 2009-10-19 |
MedTest Dx | Ferritin P1025 | 2009-10-19 |
MedTest Dx | hCG, F1027 | 2009-10-19 |
MedTest Dx | T4 T1007 | 2009-10-19 |
MedTest Dx | T3 T1005 | 2009-10-19 |
MedTest Dx | Free T3 T1006 | 2009-10-19 |
MedTest Dx | TSH T1001 | 2009-10-19 |
MedTest Dx | U-TSH T1003 | 2009-10-19 |
MedTest Dx | G7540-CTL Glycohemoglobin Control, G7540-STD Glycohemoglobin Standard | 2009-10-19 |
MedTest Dx | Pointe 180 II Chemistry Analyzer, Pointe 180 QT Chemistry Analyzer | 2009-10-19 |
MedTest Dx | Pointe 180 Chemistry Analyzer | 2009-10-19 |
MedTest Dx | Microprotein, Microprotein Standard | 2009-10-19 |
MedTest Dx | Microprotein, Microprotein Standard | 2009-10-19 |
MedTest Dx | KCL solution, HI790-KCL, HI990-KCL | 2009-10-19 |
MedTest Dx | ISE Standard Low, HI790-STL | 2009-10-19 |
MedTest Dx | ISE Standard High, HI790-STH | 2009-10-19 |
MedTest Dx | ISE Internal Reference, HI790-REF, HI990-REF | 2009-10-19 |
MedTest Dx | ISE Diluent, HI790-DIL | 2009-10-19 |
MedTest Dx | KCL solution, HI790-KCL, HI990-KCL | 2009-10-19 |
MedTest Dx | ISE Standard Low, HI790-STL | 2009-10-19 |
MedTest Dx | ISE Standard High, HI790-STH | 2009-10-19 |
MedTest Dx | ISE Internal Reference, HI790-REF, HI990-REF | 2009-10-19 |
MedTest Dx | ISE Diluent, HI790-DIL | 2009-10-19 |
MedTest Dx | KCL solution, HI790-KCL, HI990-KCL | 2009-10-19 |
MedTest Dx | ISE Standard Low, HI790-STL | 2009-10-19 |
MedTest Dx | ISE Standard High, HI790-STH | 2009-10-19 |
MedTest Dx | ISE Internal Reference, HI790-REF, HI990-REF | 2009-10-19 |
MedTest Dx | ISE Diluent, HI790-DIL | 2009-10-19 |
MedTest Dx | Microalbumin M7562, Microalbumin Calibrator M7562-CAL | 2009-10-19 |
MedTest Dx | Microalbumin M7562, Microalbumin Calibrator M7562-CAL | 2009-10-19 |
MedTest Dx | Hitachi Amylase HA965 | 2009-10-19 |
MedTest Dx | Myoglobin EIA CM1117 | 2009-10-19 |
MedTest Dx | Free T4 T1008 | 2009-10-19 |
MedTest Dx | Troponin I EIA CM1105 | 2009-10-19 |
MedTest Dx | Testosterone S1115 | 2009-10-19 |
MedTest Dx | Ammonia, Ammonia STD | 2009-10-16 |
MedTest Dx | BUN COLORMETRIC B7551 | 2009-10-16 |
MedTest Dx | MedTest DX CRP Controls (CRPQ480) | 2009-10-16 |
MedTest Dx | CRP Controls (C7568-CTL) | 2009-10-16 |
MedTest Dx | MedTest DX CRP Controls (CRPQ480) | 2009-10-16 |
MedTest Dx | CRP Controls (C7568-CTL) | 2009-10-16 |
MedTest Dx | CK-MB | 2009-01-28 |
MedTest Dx | CK-MB | 2009-01-28 |
MedTest Dx | MedTest DX Fructosamine | 2008-10-08 |
MedTest Dx | Fructosamine, Calibrator and Control | 2008-10-08 |
MedTest Dx | MedTest DX Fructosamine | 2008-10-08 |
MedTest Dx | Fructosamine, Calibrator and Control | 2008-10-08 |
MedTest Dx | auto HDL/LDL Cholesterol Calibrator | 2008-10-08 |
MedTest Dx | auto HDL Cholesterol | 2008-10-08 |
MedTest Dx | MedTest DX autoHDL Cholesterol | 2008-10-08 |
MedTest Dx | MedTest DX auto HDL/LDL Cholesterol Calibrator | 2008-10-08 |
MedTest Dx | MedTest DX Auto LDL Cholesterol | 2008-10-08 |
MedTest Dx | Auto LDL Cholesterol | 2008-10-08 |
MedTest Dx | MedTest DX Lactate Dehydrogenase | 2008-10-08 |
MedTest Dx | LD Liquid | 2008-10-08 |
MedTest Dx | MedTest DX Liquid GGT (y-glutamyl transferase) | 2008-10-08 |
MedTest Dx | Gamma GT (Liquid) | 2008-10-08 |
MedTest Dx | Alcohol | 2008-10-08 |
MedTest Dx | CK-MB Control set Level 1 and 2 | 2008-10-08 |
MedTest Dx | Medtest DX Amylase (CNPG3) | 2008-10-08 |
MedTest Dx | Amylase (CNPG3) | 2008-10-08 |
MedTest Dx | B-hydroxybutyrate, Control | 2008-10-08 |
MedTest Dx | B-hydroxybutyrate Standard | 2008-10-08 |
MedTest Dx | HDL Cholesterol Mg/Dex Standard | 2008-10-08 |
MedTest Dx | HDL Cholesterol Mg/Dex Powder | 2008-10-08 |
MedTest Dx | Alcohol Standard | 2008-10-08 |
MedTest Dx | Alcohol Control (A7506-CTL) | 2008-10-08 |
MedTest Dx | Bilirubin Calibrator Set | 2008-10-08 |
MedTest Dx | Triglycerides GPO | 2008-10-08 |
MedTest Dx | MedTest DX Triglycerides GPO | 2008-10-08 |
MedTest Dx | Glycohemoglobin | 2008-10-08 |
MedTest Dx | MedTest DX Bilirubin, Direct | 2008-10-08 |
MedTest Dx | Bilirubin, Direct | 2008-10-08 |
MedTest Dx | Chloride, Chloride Standard | 2008-10-08 |
MedTest Dx | Microprotein Control | 2008-10-08 |
MedTest Dx | Microalbumin Control Set | 2008-10-08 |
MedTest Dx | Human Urine Control Set, Urine Chemistry Control | 2008-10-08 |
MedTest Dx | Total Protein Standard | 2008-10-08 |
MedTest Dx | Protein, Total | 2008-10-08 |
MedTest Dx | MedTest DX Total Protein | 2008-10-08 |
MedTest Dx | LD | 2008-10-08 |
MedTest Dx | ALT | 2008-10-08 |
MedTest Dx | HDL Cholesterol PEG | 2008-10-08 |
MedTest Dx | Gamma GT Powder | 2008-10-08 |
MedTest Dx | MedTest DX Cholesterol Liquid | 2008-10-08 |
MedTest Dx | Cholesterol Powder and Cholesterol Liquid | 2008-10-08 |
MedTest Dx | Ammonia/Alcohol Control Set | 2008-10-08 |
MedTest Dx | MedTest DX Direct TIBC Calibrator | 2008-10-08 |
MedTest Dx | Direct TIBC Calibrator | 2008-10-08 |
MedTest Dx | G6PD | 2008-10-08 |
MedTest Dx | G6PD Reagent | 2008-10-08 |
MedTest Dx | G6PD Lyse | 2008-10-08 |
MedTest Dx | MedTest DX Direct TIBC | 2008-10-08 |
MedTest Dx | Iron Standard AW | 2008-10-08 |
MedTest Dx | Direct TIBC | 2008-10-08 |
MedTest Dx | Lactate | 2008-10-08 |
MedTest Dx | HBDH | 2008-10-08 |
MedTest Dx | MedTest DX Alkaline Phosphatase Liquid | 2007-12-13 |
MedTest Dx | Alkaline Phosphatase Liquid | 2007-12-13 |
MedTest Dx | MedTest DX BUN | 2007-12-13 |
MedTest Dx | BUN | 2007-12-13 |
MedTest Dx | BUN (Colorimetric) | 2007-12-13 |
MedTest Dx | MedTest DX Creatine Kinase | 2007-12-13 |
MedTest Dx | Creatine Kinase, CK Liquid | 2007-12-13 |
MedTest Dx | Glucose - Oxidase Liquid | 2007-12-13 |
MedTest Dx | Uric Acid | 2007-12-13 |
MedTest Dx | MedTest DX Uric Acid | 2007-12-13 |
MedTest Dx | MedTest DX AST Liquid | 2007-12-13 |
MedTest Dx | AST Liquid | 2007-12-13 |
MedTest Dx | Calcium - Arsenazo III | 2007-12-13 |
MedTest Dx | Calcium | 2007-12-13 |
MedTest Dx | Total Iron | 2007-12-13 |
MedTest Dx | MedTest DX Iron | 2007-12-13 |
MedTest Dx | Iron Standard | 2007-12-13 |
MedTest Dx | Iron - Ferrozine, IBC, UIBC Buffer | 2007-12-13 |
MedTest Dx | Acid Phosphatase | 2007-12-13 |
MedTest Dx | MedTest DX Magnesium | 2007-12-13 |
MedTest Dx | Magnesium, Magnesium Standard | 2007-12-13 |
MedTest Dx | Hemoglobin | 2007-12-13 |
MedTest Dx | Hemoglobin Standard | 2007-12-13 |
MedTest Dx | Glucose - Hexokinase Powder | 2007-12-13 |
MedTest Dx | Total Bilirubin | 2007-12-13 |
MedTest Dx | MedTest DX Total Bilirubin | 2007-12-13 |
MedTest Dx | MedTest DX Creatinine | 2007-12-13 |
MedTest Dx | Creatinine | 2007-12-13 |
MedTest Dx | Creatinine Standard | 2007-12-13 |
MedTest Dx | MedTest DX Albumin | 2007-12-13 |
MedTest Dx | Albumin | 2007-12-13 |
MedTest Dx | Albumin Standard | 2007-12-13 |
MedTest Dx | Phosphorus | 2007-12-13 |
MedTest Dx | Phosphorus Standard | 2007-12-13 |
MedTest Dx | MedTest DX Phosphorus | 2007-12-13 |
MedTest Dx | MedTest DX Calcium CPC | 2007-12-13 |
MedTest Dx | Calcium-CPC | 2007-12-13 |
MedTest Dx | Calcium Standard | 2007-12-13 |
MedTest Dx | CPK | 2007-12-13 |
MedTest Dx | AST Powder | 2007-12-13 |
MedTest Dx | Alkaline Phosphatase | 2007-12-13 |
MedTest Dx | Uric Acid and Uric Acid Standard | 2007-12-13 |
MedTest Dx | BUN Standard | 2007-12-13 |
MedTest Dx | BUN Powder | 2007-12-13 |
MedTest Dx | Glucose Standard | 2007-12-13 |
MedTest Dx | Glucose - Oxidase Powder | 2007-12-13 |
MedTest Dx | Hemoglobin Controls | 2007-12-13 |
MedTest Dx | MedTest DX Carbon Dioxide - CO2 | 2007-12-13 |
MedTest Dx | Carbon Dioxide - CO2 | 2007-12-13 |
MedTest Dx | Multi-Analyte Chemistry Calibrator | 2007-12-13 |
MedTest Dx | MedTest DX Multi-Analyte Chemistry Calibrator | 2007-12-13 |
MedTest Dx | Calibrator Diluent | 2007-12-13 |
MedTest Dx | Total Bilirubin | 2007-12-13 |
MedTest Dx | Direct Bilirubin | 2007-12-13 |
MedTest Dx | MedTest DX Hemoglobin A1c Reagent Set (HBA480, HBA600), Hemoglobin A1c Calibrators (HBAC480) | 2007-12-13 |
MedTest Dx | Hemoglobin A1c Reagent Set (H7546), Hemoglobin A1c Calibrators (H7546-CAL) | 2007-12-13 |
MedTest Dx | Hemoglobin A1c Reagent Set (H7541), Hemoglboin A1c Calibrators (H7541-CAL), Hemoglobin A1c Controls (H7541-CTL) | 2007-12-13 |
MedTest Dx | TRIGLYCERIDES | 1992-12-16 |
MedTest Dx | MedTest DX Lipase (Colormetric) Reagent | 1992-12-16 |
MedTest Dx | Lipase Standard | 1992-12-16 |
MedTest Dx | Lipase (Colormetric) Reagent | 1992-12-16 |
MedTest Dx | LIPASE HYDROLYSIS-GLYCEROL KINASE E | 1992-12-16 |
MedTest Dx | IDES | 1992-12-16 |
MedTest Dx | Pointe 180 SR | 1992-12-16 |
MedTest Dx | Wash Concentrate and Wash Solution | 1992-12-16 |
MedTest Dx | MedTest DX Wash Solution | 1992-12-16 |
MedTest Dx | MedTest DX C1 Cleaning Solution or Medtest DX Cleaning Solution | 1992-12-16 |
MedTest Dx | 10W500 MedTest DX Wash Concentrate Solution 3 | 1992-12-16 |
MedTest Dx | 09W500 MedTest DX Wash Concentrate Solution 2 | 1992-12-16 |
MedTest Dx | 03W500 MedTest DX Wash Concentrate Solution 1 | 1992-12-16 |
MedTest Dx | MedTest DX Alanine Aminotransferase, MedTest DX ALT Liquid | 1992-12-16 |
MedTest Dx | ALANINE AMINOTRANSFERASE, ALT Liquid | 1992-12-16 |
MedTest Dx | TRIGLYCERIDES | 1992-12-16 |
MedTest Dx | Cholesterol Standard | 1992-12-16 |
MedTest Dx | CHOLESTEROL | 1992-12-16 |
MedTest Dx | Lactate Standard | 1992-12-16 |
MedTest Dx | LACTATE DEHYDROGENASE | 1992-12-16 |
MedTest Dx | TOTAL PROTEIN | 1992-12-16 |