FDA 510(k) Cleared 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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DZ152A | Anhydroglucitol (1,5 AG) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
510(k) Cleared | ||
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DZ141A | Apolipoprotein A-1 (APO A-1) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ142A | Apolipoprotein B (APO B) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ153A | β-Hydroxybutyrate (BHB) Assay | (Dual Vial Liquid Stable) (Enzymatic Colorimetric) |
510(k) Exempt | |||
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DZ122A | Carbon Dioxide (CO2) Assay | (Single Vial Liquid Stable) (Enzyme Cycling 405nm) |
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DZ072B | Creatinine Assay | (Dual Vial Liquid Stable) (Enzymatic) |
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DZ133C | Cystatin C Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ179A | D-Dimer Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ168A | Direct Enzymatic HbA1c Assay | (Liquid Stable) (Single Channel) |
![]() Health Canada Registered |
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DZ168C | Direct HbA1c Assay (Enzymatic, On-Board Lysis) | (Dual Vial Liquid Stable) (Enzymatic) |
![]() Health Canada Registered |
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DZ768A | Fibrinogen Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
510(k) Cleared | ||
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DZ169A | Human Kappa κ Free Light Chain Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
![]() Health Canada Registered |
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DZ170A | Human Lambda λ Free Light Chain Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
![]() Health Canada Registered |
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DZ112B | Glycated Serum Protein (GSP) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
![]() Health Canada Registered |
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DZ129A | HDL-Cholesterol Assay | (Dual Vial Liquid Stable) (PVS\PEGME Coupled) |
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DZ568A | Homocysteine Assay | (Three Vial Liquid Stable) (Enzyme Cycling) |
![]() Health Canada Registered |
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DZ568B | Homocysteine Assay | (Dual Vial Liquid Stable) (Enzyme Cycling) |
![]() Health Canada Registered |
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DZ135A | hsCRP Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ128A | LDL-Cholesterol Assay | (Dual Vial Liquid Stable) (PVS\PEGME Coupled) |
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DZ132A | Lipase Assay | (Dual Vial Liquid Stable) (Methyl-Resorufin) |
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DZ131B | Lipoprotein (a) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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10-0148 | PLAC® Test for Lp-PLA2 Activity | (Dual Vial Liquid Stable) (Enzymatic) |
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DZ116B | Lithium Assay | (Dual Vial Liquid Stable) (Enzymatic) | ![]() Health Canada Registered |
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DZ147A | Myoglobin Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ123A | Nucleotidase (5’NT) Assay | (Dual Vial Liquid Stable) (Enzymatic) |
![]() Health Canada Registered |
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DZ113C | Potassium Assay | (Dual Vial Liquid Stable) (Enzymatic) |
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DZ558A | Procalcitonin (PCT) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
![]() Health Canada Registered |
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DZ187A | Retinol Binding Protein (RBP) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) |
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DZ114B | Sodium Assay | (Dual Vial Liquid Stable) (Enzymatic) |
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DZ042A | Total Bile Acids (TBA) Assay | (Dual Vial Liquid Stable) (Enzyme Cycling) |
![]() Health Canada Registered |
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DZ888A | Vitamin D (EZ Vitamin D) Assay | (Dual Vial Liquid Stable) (Immunoturbidimetric) | ![]() |