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
0-9
1,5-Anhydroglucitol GlycoMark<sup>®</sup> (1,5-AG) Assay NK-8300 1,5-Anhydroglucitol GlycoMark® (1,5-AG) Assay (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Cleared
2-Reagent EZ Vitamin D Assay DZ888A 2-Reagent EZ Vitamin D Assay (Dual Vial Liquid Stable) (Immunoturbidimetric) 510(k) Cleared
5'-Nucleotidase (5'NT) Assay DZ123A 5'-Nucleotidase (5'NT) Assay (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Exempt
Health Canada Registered
A top
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
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
D top
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
F top
Ferritin Assay DZ526A Ferritin Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
Folate Assay DZ690A Folate Assay (Four Vial Liquid Stable)
(Enzyme Immunoassay)
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
G top
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
L top
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) Lp(a) Assay DZ131B Lipoprotein (a) Lp(a) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
PLAC<sup>®</sup> Test for Lp-PLA<sub>2</sub> Activity DZ10-0148 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
P top
Potassium Assay DZ113C Potassium Assay (Dual Vial Liquid Stable)
(Enzymatic)
510(k) Cleared
Procalcitonin (PCT) Assay DZ558A Procalcitonin (PCT) Assay (Dual Vial Liquid Stable)
(Immunoturbidimetric)
510(k) Cleared
Health Canada Registered
R top
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
Vitamin B12 Assay DZ689A Vitamin B12 Assay (Four Vial Liquid Stable)
(Enzyme Immunoassay)
510(k) Cleared