EU: CE IVDD Products
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Catalog No. | Assay | Method | Regulatory Status | |||
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DZ869A | α-Fetoprotein (AFP) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ082B | α-L-Fucosidase (AFU) Assay | (Single Vial Liquid Stable) (Enzymatic) |
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DZ117A | Adenosine Deaminase (ADA) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
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DZ141A | Apolipoprotein A-1 (APO A-1) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
DZ142A | Apolipoprotein B (APO B) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
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DZ202A | Calprotectin Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
DZ145A | Cardiac Troponin I Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ122A | Carbon Dioxide (CO2) Assay | (Single Vial Liquid Stable) (Enzyme Cycling 405nm) |
510(k) Cleared | |||
DZ863A | Carcinoembryonic Antigen (CEA) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ072B | Creatinine Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared | |||
DZ133C | Cystatin C Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
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DZ179A | D-Dimer Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
DZ168A | Direct Enzymatic HbA1c Assay | (Liquid Stable) (Single Channel) |
510(k) Cleared Health Canada Registered |
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DZ168C | Direct HbA1c Assay (Enzymatic, On-Board Lysis) | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared Health Canada Registered |
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DZ169A | Human Kappa κ Free Light Chain Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared Health Canada Registered |
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DZ170A | Human Lambda λ Free Light Chain Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared Health Canada Registered |
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DZ112B | Glycated Serum Protein (GSP) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared Health Canada Registered |
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DZ129A | HDL-Cholesterol Assay | (Dual Vial Liquid Stable) (PVS\PEGME Coupled) |
510(k) Cleared | |||
DZ785A | Heart-Type Fatty Acid-Binding Protein (H-FABP) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ568A | Homocysteine Assay | (Three Vial Liquid Stable) (Enzyme Cycling) |
510(k) Cleared Health Canada Registered |
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DZ568B | Homocysteine Assay | (Dual Vial Liquid Stable) (Enzyme Cycling) |
510(k) Cleared Health Canada Registered |
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DZ135A | hsCRP Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
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DZ128A | LDL-Cholesterol Assay | (Dual Vial Liquid Stable) (PVS\PEGME Coupled) |
510(k) Cleared | |||
DZ132A | Lipase Assay | (Dual Vial Liquid Stable) (Methyl-Resorufin) |
510(k) Exempt | |||
DZ131B | Lipoprotein (a) Lp(a) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
10-0148 | PLAC® Test for Lp-PLA2 Activity | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared | |||
DZ116B | Lithium Assay | (Dual Vial Liquid Stable) (Enzymatic) | 510(k) Cleared Health Canada Registered |
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DZ178C | Myeloperoxidase (MPO) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ147A | Myoglobin Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | |||
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DZ062A | N-Acetyl-ß-D-Glucosaminidase (NAG) Assay | (Three Vial Liquid Stable) (Colorimetric) |
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DZ123A | Nucleotidase (5’NT) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Exempt Health Canada Registered |
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DZ113C | Potassium Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared | |||
DZ558A | Procalcitonin (PCT) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared Health Canada Registered |
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DZ187A | Retinol Binding Protein (RBP) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Exempt | |||
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DZ114B | Sodium Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared | |||
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DZ042A | Total Bile Acids (TBA) Assay | (Dual Vial Liquid Stable) (Enzyme Cycling) |
510(k) Cleared Health Canada Registered |
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DZ888A | Vitamin D (EZ Vitamin D) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) | 510(k) Cleared |