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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Anhydroglucitol (1,5 AG) Assay DZ152A Anhydroglucitol (1,5 AG) Assay (Dual Vial Liquid Stable)
(Enzymatic)		 510(k) Cleared
Apolipoprotein A-1 (APO A-1) Assay DZ141A Apolipoprotein A-1 (APO A-1) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
Apolipoprotein B (APO B) Assay DZ142A Apolipoprotein B (APO B) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
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DZ153A β-Hydroxybutyrate (BHB) Assay (Dual Vial Liquid Stable)
(Enzymatic Colorimetric)		 510(k) Exempt
C top
Carbon Dioxide (CO<sub>2</sub>) Assay DZ122A Carbon Dioxide (CO2) Assay (Single Vial Liquid Stable)
(Enzyme Cycling 405nm)		 510(k) Cleared
Creatinine Assay DZ072B Creatinine Assay (Dual Vial Liquid Stable)
(Enzymatic)		 510(k) Cleared
Cystatin C Assay DZ133C Cystatin C Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
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D-Dimer Assay DZ179A D-Dimer Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
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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Fibrinogen Assay DZ768A Fibrinogen Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
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
H top
HDL-Cholesterol Assay DZ129A HDL-Cholesterol Assay (Dual Vial Liquid Stable)
(PVS\PEGME Coupled)		 510(k) Cleared
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
hsCRP Assay DZ135A hsCRP Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
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LDL-Cholesterol Assay DZ128A LDL-Cholesterol Assay (Dual Vial Liquid Stable)
(PVS\PEGME Coupled)		 510(k) Cleared
Lipase Assay DZ132A Lipase Assay (Dual Vial Liquid Stable)
(Methyl-Resorufin)		 510(k) Exempt
Lipoprotein (a) Assay DZ131B Lipoprotein (a) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
PLAC<sup>®</sup> Test for Lp-PLA<sub>2</sub> Activity 10-0148 PLAC® Test for Lp-PLA2 Activity (Dual Vial Liquid Stable)
(Enzymatic)		 510(k) Cleared
Lithium Assay DZ116B Lithium Assay (Dual Vial Liquid Stable) (Enzymatic) 510(k) Cleared
Health Canada Registered
M top
Myoglobin Assay DZ147A Myoglobin Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Cleared
N top
Nucleotidase (5’NT) Assay DZ123A Nucleotidase (5’NT) Assay (Dual Vial Liquid Stable)
(Enzymatic)		 510(k) Exempt
Health Canada Registered
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Potassium Assay 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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Retinol Binding Protein (RBP) Assay DZ187A Retinol Binding Protein (RBP) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)		 510(k) Exempt
S top
Sodium Assay DZ114B Sodium Assay (Dual Vial Liquid Stable)
(Enzymatic)		 510(k) Cleared
T top
Total Bile Acids (TBA) Assay DZ042A Total Bile Acids (TBA) Assay (Dual Vial Liquid Stable)
(Enzyme Cycling)		 510(k) Cleared
Health Canada Registered
V top
EZ Vitamin D Assay (2-Reagent) DZ888A Vitamin D (EZ Vitamin D) Assay (Dual Vial Liquid Stable) (Immunoturbidimetric) 510(k) Cleared