Medtest Dx

FDA Filings

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.

FDA Registration(s)
Registration Number1827821
FEI Number1827821
NameMedTest Dx
Owner & OperatorMedTest Dx
Contact Address5449 RESEARCH DRIVE --
Canton MI 48188 US
Official Correspondent
  • William Cripps
  • x-734-4878300-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5449 RESEARCH DRIVE
Canton Twp, MI 48188 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
MedTest Dx
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
MedTest Dx
Pointe 180 impulse Analyzer2019-11-18
MedTest Dx
Pointe 180 impulse Analyzer2019-11-18
MedTest Dx
Pointe 180 impulse Analyzer2019-11-18
MedTest Dx
Pointe 180 impulse Analyzer2019-11-18
MedTest Dx
BA-800M Automated Chemistry Analyzer2019-11-18
MedTest Dx
BA-800M Automated Chemistry Analyzer2019-11-18
MedTest Dx
BA-800M Automated Chemistry Analyzer2019-11-18
MedTest Dx
BA-800M Automated Chemistry Analyzer2019-11-18
MedTest Dx
BA-800M Automated Chemistry Analyzer2019-11-18
MedTest Dx
BS-480 Automated Chemistry Analyzer2019-11-18
MedTest Dx
BS-480 Automated Chemistry Analyzer2019-11-18
MedTest Dx
BS-480 Automated Chemistry Analyzer2019-11-18
MedTest Dx
BS-480 Automated Chemistry Analyzer2019-11-18
MedTest Dx
BS-480 Automated Chemistry Analyzer2019-11-18
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 Reagent2018-05-14
MedTest Dx
MedTest DX Direct HDL/LDL Cholesterol Calibrator2016-12-02
MedTest Dx
MedTest DX Lactate, MedTest DX Lactate Standard2016-09-26
MedTest Dx
Lactate2016-09-26
MedTest Dx
Lactate Standard2016-09-26
MedTest Dx
MedTest DX Calibration Serum Level 22016-09-26
MedTest Dx
MedTest DX Reconstitution Fluid2016-09-26
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 12016-09-26
MedTest Dx
MedTest DX Fructosamine2016-09-26
MedTest Dx
MedTest DX Fructosamine Controls2016-09-26
MedTest Dx
MedTest DX Fructosamine Calibrators2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a)2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a) Calibrators2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a)2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a) Calibrators2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a)2016-09-26
MedTest Dx
MedTest DX Lipoprotein (a) Calibrators2016-09-26
MedTest Dx
3-H7590-R1 HDL-C R1 and 3-H7590-R2 HDL-C R22016-09-08
MedTest Dx
3003 Direct Lipid Control L32016-08-18
MedTest Dx
3002 Direct Lipid Control L22016-08-18
MedTest Dx
3001 Direct Lipid Control L12016-08-18
MedTest Dx
3000 Direct Lipid Control Set2016-08-18
MedTest Dx
MedTest DX Lipid Control Set2016-07-21
MedTest Dx
Lipid Control Set2016-07-21
MedTest Dx
S1113 Progesterone2016-07-21
MedTest Dx
S1111 Estradiol2016-07-21
MedTest Dx
S1887 Cortisol2016-07-21
MedTest Dx
MedTest DX Homocysteine Controls2016-05-03
MedTest Dx
Homocysteine Controls2016-05-03
MedTest Dx
MedTest DX Homocysteine Controls2016-05-03
MedTest Dx
Homocysteine Controls2016-05-03
MedTest Dx
MedTest DX Homocysteine Controls2016-05-03
MedTest Dx
Homocysteine Controls2016-05-03
MedTest Dx
MedTest DX Homocysteine2016-05-03
MedTest Dx
Homocysteine Calibrator2016-05-03
MedTest Dx
HOMOCYSTEINE2016-05-03
MedTest Dx
MedTest DX Homocysteine2016-05-03
MedTest Dx
Homocysteine Calibrator2016-05-03
MedTest Dx
HOMOCYSTEINE2016-05-03
MedTest Dx
c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer2015-11-19
MedTest Dx
Mindray BS-200 Chemistry Analyzer2015-11-19
MedTest Dx
c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer2015-11-19
MedTest Dx
Mindray BS-200 Chemistry Analyzer2015-11-19
MedTest Dx
c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer2015-11-19
MedTest Dx
Mindray BS-200 Chemistry Analyzer2015-11-19
MedTest Dx
c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer2015-11-19
MedTest Dx
Mindray BS-200 Chemistry Analyzer2015-11-19
MedTest Dx
c2000 Chemistry Analyzer, Pointe c2000 Chemistry Analyzer2015-11-19
MedTest Dx
Mindray BS-200 Chemistry Analyzer2015-11-19
MedTest Dx
MedTest DX Chemistry Controls2015-10-28
MedTest Dx
Chemistry Controls2015-10-28
MedTest Dx
Random Access Fluid2014-12-08
MedTest Dx
F1029 FSH2014-12-08
MedTest Dx
F1037 Prolactin2014-12-08
MedTest Dx
F1031 LH2014-12-08
MedTest Dx
Triglyceride Std2014-12-05
MedTest Dx
T8006 CMV IgM2014-12-02
MedTest Dx
T8004 Rubella IgM2014-12-02
MedTest Dx
T8002 Toxoplasma IgM2014-12-02
MedTest Dx
T8007 HSV IgG2014-12-02
MedTest Dx
T8003 Rubella IgG2014-12-02
MedTest Dx
T8001 Toxoplasma IgG2014-12-02
MedTest Dx
T8005 CMV IgG2014-12-02
MedTest Dx
CO2 Standard2014-09-12
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 Hexokinase2010-11-23
MedTest Dx
Liquid Stable Glucose Hexokinase2010-11-23
MedTest Dx
IgE P10352009-10-19
MedTest Dx
Ferritin P10252009-10-19
MedTest Dx
hCG, F10272009-10-19
MedTest Dx
T4 T10072009-10-19
MedTest Dx
T3 T10052009-10-19
MedTest Dx
Free T3 T10062009-10-19
MedTest Dx
TSH T10012009-10-19
MedTest Dx
U-TSH T10032009-10-19
MedTest Dx
G7540-CTL Glycohemoglobin Control, G7540-STD Glycohemoglobin Standard2009-10-19
MedTest Dx
Pointe 180 II Chemistry Analyzer, Pointe 180 QT Chemistry Analyzer2009-10-19
MedTest Dx
Pointe 180 Chemistry Analyzer2009-10-19
MedTest Dx
Microprotein, Microprotein Standard2009-10-19
MedTest Dx
Microprotein, Microprotein Standard2009-10-19
MedTest Dx
KCL solution, HI790-KCL, HI990-KCL2009-10-19
MedTest Dx
ISE Standard Low, HI790-STL2009-10-19
MedTest Dx
ISE Standard High, HI790-STH2009-10-19
MedTest Dx
ISE Internal Reference, HI790-REF, HI990-REF2009-10-19
MedTest Dx
ISE Diluent, HI790-DIL2009-10-19
MedTest Dx
KCL solution, HI790-KCL, HI990-KCL2009-10-19
MedTest Dx
ISE Standard Low, HI790-STL2009-10-19
MedTest Dx
ISE Standard High, HI790-STH2009-10-19
MedTest Dx
ISE Internal Reference, HI790-REF, HI990-REF2009-10-19
MedTest Dx
ISE Diluent, HI790-DIL2009-10-19
MedTest Dx
KCL solution, HI790-KCL, HI990-KCL2009-10-19
MedTest Dx
ISE Standard Low, HI790-STL2009-10-19
MedTest Dx
ISE Standard High, HI790-STH2009-10-19
MedTest Dx
ISE Internal Reference, HI790-REF, HI990-REF2009-10-19
MedTest Dx
ISE Diluent, HI790-DIL2009-10-19
MedTest Dx
Microalbumin M7562, Microalbumin Calibrator M7562-CAL2009-10-19
MedTest Dx
Microalbumin M7562, Microalbumin Calibrator M7562-CAL2009-10-19
MedTest Dx
Hitachi Amylase HA9652009-10-19
MedTest Dx
Myoglobin EIA CM11172009-10-19
MedTest Dx
Free T4 T10082009-10-19
MedTest Dx
Troponin I EIA CM11052009-10-19
MedTest Dx
Testosterone S11152009-10-19
MedTest Dx
Ammonia, Ammonia STD2009-10-16
MedTest Dx
BUN COLORMETRIC B75512009-10-16
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-MB2009-01-28
MedTest Dx
CK-MB2009-01-28
MedTest Dx
MedTest DX Fructosamine2008-10-08
MedTest Dx
Fructosamine, Calibrator and Control2008-10-08
MedTest Dx
MedTest DX Fructosamine2008-10-08
MedTest Dx
Fructosamine, Calibrator and Control2008-10-08
MedTest Dx
auto HDL/LDL Cholesterol Calibrator2008-10-08
MedTest Dx
auto HDL Cholesterol2008-10-08
MedTest Dx
MedTest DX autoHDL Cholesterol2008-10-08
MedTest Dx
MedTest DX auto HDL/LDL Cholesterol Calibrator2008-10-08
MedTest Dx
MedTest DX Auto LDL Cholesterol2008-10-08
MedTest Dx
Auto LDL Cholesterol2008-10-08
MedTest Dx
MedTest DX Lactate Dehydrogenase2008-10-08
MedTest Dx
LD Liquid2008-10-08
MedTest Dx
MedTest DX Liquid GGT (y-glutamyl transferase)2008-10-08
MedTest Dx
Gamma GT (Liquid)2008-10-08
MedTest Dx
Alcohol2008-10-08
MedTest Dx
CK-MB Control set Level 1 and 22008-10-08
MedTest Dx
Medtest DX Amylase (CNPG3)2008-10-08
MedTest Dx
Amylase (CNPG3)2008-10-08
MedTest Dx
B-hydroxybutyrate, Control2008-10-08
MedTest Dx
B-hydroxybutyrate Standard2008-10-08
MedTest Dx
HDL Cholesterol Mg/Dex Standard2008-10-08
MedTest Dx
HDL Cholesterol Mg/Dex Powder2008-10-08
MedTest Dx
Alcohol Standard2008-10-08
MedTest Dx
Alcohol Control (A7506-CTL)2008-10-08
MedTest Dx
Bilirubin Calibrator Set2008-10-08
MedTest Dx
Triglycerides GPO2008-10-08
MedTest Dx
MedTest DX Triglycerides GPO2008-10-08
MedTest Dx
Glycohemoglobin2008-10-08
MedTest Dx
MedTest DX Bilirubin, Direct2008-10-08
MedTest Dx
Bilirubin, Direct2008-10-08
MedTest Dx
Chloride, Chloride Standard2008-10-08
MedTest Dx
Microprotein Control2008-10-08
MedTest Dx
Microalbumin Control Set2008-10-08
MedTest Dx
Human Urine Control Set, Urine Chemistry Control2008-10-08
MedTest Dx
Total Protein Standard2008-10-08
MedTest Dx
Protein, Total2008-10-08
MedTest Dx
MedTest DX Total Protein2008-10-08
MedTest Dx
LD2008-10-08
MedTest Dx
ALT2008-10-08
MedTest Dx
HDL Cholesterol PEG2008-10-08
MedTest Dx
Gamma GT Powder2008-10-08
MedTest Dx
MedTest DX Cholesterol Liquid2008-10-08
MedTest Dx
Cholesterol Powder and Cholesterol Liquid2008-10-08
MedTest Dx
Ammonia/Alcohol Control Set2008-10-08
MedTest Dx
MedTest DX Direct TIBC Calibrator2008-10-08
MedTest Dx
Direct TIBC Calibrator2008-10-08
MedTest Dx
G6PD2008-10-08
MedTest Dx
G6PD Reagent2008-10-08
MedTest Dx
G6PD Lyse2008-10-08
MedTest Dx
MedTest DX Direct TIBC2008-10-08
MedTest Dx
Iron Standard AW2008-10-08
MedTest Dx
Direct TIBC2008-10-08
MedTest Dx
Lactate2008-10-08
MedTest Dx
HBDH2008-10-08
MedTest Dx
MedTest DX Alkaline Phosphatase Liquid2007-12-13
MedTest Dx
Alkaline Phosphatase Liquid2007-12-13
MedTest Dx
MedTest DX BUN2007-12-13
MedTest Dx
BUN2007-12-13
MedTest Dx
BUN (Colorimetric)2007-12-13
MedTest Dx
MedTest DX Creatine Kinase2007-12-13
MedTest Dx
Creatine Kinase, CK Liquid2007-12-13
MedTest Dx
Glucose - Oxidase Liquid2007-12-13
MedTest Dx
Uric Acid2007-12-13
MedTest Dx
MedTest DX Uric Acid2007-12-13
MedTest Dx
MedTest DX AST Liquid2007-12-13
MedTest Dx
AST Liquid2007-12-13
MedTest Dx
Calcium - Arsenazo III2007-12-13
MedTest Dx
Calcium2007-12-13
MedTest Dx
Total Iron2007-12-13
MedTest Dx
MedTest DX Iron2007-12-13
MedTest Dx
Iron Standard2007-12-13
MedTest Dx
Iron - Ferrozine, IBC, UIBC Buffer2007-12-13
MedTest Dx
Acid Phosphatase2007-12-13
MedTest Dx
MedTest DX Magnesium2007-12-13
MedTest Dx
Magnesium, Magnesium Standard2007-12-13
MedTest Dx
Hemoglobin2007-12-13
MedTest Dx
Hemoglobin Standard2007-12-13
MedTest Dx
Glucose - Hexokinase Powder2007-12-13
MedTest Dx
Total Bilirubin2007-12-13
MedTest Dx
MedTest DX Total Bilirubin2007-12-13
MedTest Dx
MedTest DX Creatinine2007-12-13
MedTest Dx
Creatinine2007-12-13
MedTest Dx
Creatinine Standard2007-12-13
MedTest Dx
MedTest DX Albumin2007-12-13
MedTest Dx
Albumin2007-12-13
MedTest Dx
Albumin Standard2007-12-13
MedTest Dx
Phosphorus2007-12-13
MedTest Dx
Phosphorus Standard2007-12-13
MedTest Dx
MedTest DX Phosphorus2007-12-13
MedTest Dx
MedTest DX Calcium CPC2007-12-13
MedTest Dx
Calcium-CPC2007-12-13
MedTest Dx
Calcium Standard2007-12-13
MedTest Dx
CPK2007-12-13
MedTest Dx
AST Powder2007-12-13
MedTest Dx
Alkaline Phosphatase2007-12-13
MedTest Dx
Uric Acid and Uric Acid Standard2007-12-13
MedTest Dx
BUN Standard2007-12-13
MedTest Dx
BUN Powder2007-12-13
MedTest Dx
Glucose Standard2007-12-13
MedTest Dx
Glucose - Oxidase Powder2007-12-13
MedTest Dx
Hemoglobin Controls2007-12-13
MedTest Dx
MedTest DX Carbon Dioxide - CO22007-12-13
MedTest Dx
Carbon Dioxide - CO22007-12-13
MedTest Dx
Multi-Analyte Chemistry Calibrator2007-12-13
MedTest Dx
MedTest DX Multi-Analyte Chemistry Calibrator2007-12-13
MedTest Dx
Calibrator Diluent2007-12-13
MedTest Dx
Total Bilirubin2007-12-13
MedTest Dx
Direct Bilirubin2007-12-13
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
TRIGLYCERIDES1992-12-16
MedTest Dx
MedTest DX Lipase (Colormetric) Reagent1992-12-16
MedTest Dx
Lipase Standard1992-12-16
MedTest Dx
Lipase (Colormetric) Reagent1992-12-16
MedTest Dx
LIPASE HYDROLYSIS-GLYCEROL KINASE E1992-12-16
MedTest Dx
IDES1992-12-16
MedTest Dx
Pointe 180 SR1992-12-16
MedTest Dx
Wash Concentrate and Wash Solution1992-12-16
MedTest Dx
MedTest DX Wash Solution1992-12-16
MedTest Dx
MedTest DX C1 Cleaning Solution or Medtest DX Cleaning Solution1992-12-16
MedTest Dx
10W500 MedTest DX Wash Concentrate Solution 31992-12-16
MedTest Dx
09W500 MedTest DX Wash Concentrate Solution 21992-12-16
MedTest Dx
03W500 MedTest DX Wash Concentrate Solution 11992-12-16
MedTest Dx
MedTest DX Alanine Aminotransferase, MedTest DX ALT Liquid1992-12-16
MedTest Dx
ALANINE AMINOTRANSFERASE, ALT Liquid1992-12-16
MedTest Dx
TRIGLYCERIDES1992-12-16
MedTest Dx
Cholesterol Standard1992-12-16
MedTest Dx
CHOLESTEROL1992-12-16
MedTest Dx
Lactate Standard1992-12-16
MedTest Dx
LACTATE DEHYDROGENASE1992-12-16
MedTest Dx
TOTAL PROTEIN1992-12-16

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