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 |