Health Canada Registered Products

Catalog No. Assay Method Regulatory Status
D top
Direct Enzymatic HbA1c Assay DZ168A Direct Enzymatic HbA1c Assay (Liquid Stable)
(Single Channel)
510(k) Cleared
Health Canada Registered
Direct HbA1c Assay (Enzymatic, On-Board Lysis) DZ168C Direct HbA1c Assay (Enzymatic, On-Board Lysis) (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Cleared
Health Canada Registered
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Human Kappa κ Free Light Chain Assay DZ169A Human Kappa κ Free Light Chain Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
Health Canada Registered
Human Lambda λ Free Light Chain Assay DZ170A Human Lambda λ Free Light Chain Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
Health Canada Registered
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Glycated Serum Protein (GSP) Assay DZ112B Glycated Serum Protein (GSP) Assay (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Cleared
Health Canada Registered
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Homocysteine Assay DZ568A Homocysteine Assay (Three Vial Liquid Stable)
(Enzyme Cycling)
510(k) Cleared
Health Canada Registered
Homocysteine Assay DZ568B Homocysteine Assay (Dual Vial Liquid Stable)
(Enzyme Cycling)
510(k) Cleared
Health Canada Registered
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Lithium Assay DZ116B Lithium Assay (Dual Vial Liquid Stable) (Enzymatic) 510(k) Cleared
Health Canada Registered
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5'-Nucleotidase (5'NT) Assay DZ123A Nucleotidase (5’NT) Assay (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Exempt
Health Canada Registered
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DZ558A Procalcitonin (PCT) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
Health Canada Registered
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Total Bile Acids (TBA) Assay DZ042A Total Bile Acids (TBA) Assay (Dual Vial Liquid Stable)
(Enzyme Cycling)
510(k) Cleared
Health Canada Registered