CRP Reagent
(C-Reactive Protein)
Cat. No.: KAI-026
Type: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 1 – 250 mg/L or 0.1 – 25.0 mg/dL
Sample: Serum
Kit Composition:
R1: 4 x 20 mL buffer
R2: 2 x 10 mL antibody
Tests / Kit: 285 (Hitachi 717)
(Can Vary Based On Analyzer Model)
 
Intended Use
For the quantitative determination of C-reactive protein (CRP) in serum by immunoturbidimetric assay. Measurement of CRP aids in the evaluation of the amount of injury to body tissues.
FOR IN VITRO DIAGNOSTIC USE.
 
Reagent Preparation
The reagents are ready to use and do not require reconstitution.
 
Storage and Handling
All reagents should be stored refrigerated (2–8°C). Return all reagents to 2–8°C promptly after use. Unopened reagents can be used for one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels. Opened reagents can be used for one month if stored at 2–8°C.
 
Diagnostic Catalog
Example Package Insert
Safety Data Sheets:
Reagent-1 (R-1)
Reagent-2 (R-2)
                                                                                            
 
CRP Calibrator
Cat. No.: KAI-012C
Type: Calibrator
Kit Composition:
Calibrator A: 150 mM Sodium Chloride, 1 x 1 mL
Calibrator B-F: Human CRP, 5 x 1 mL
 
Intended Use
The K-ASSAY® CRP Calibrator is intended to be used for the calibration of the K-ASSAY® CRP immunoturbidimetric assay (Cat. No. KAI-026) for quantifying serum levels of C-Reactive Protein (CRP).
FOR IN VITRO DIAGNOSTIC USE.
 
Calibrator Preparation
The calibrators are ready to use and do not require reconstitution.
 
Storage and Handling
All calibrators should be stored refrigerated (2–8°C). Return all calibrators to 2–8°C promptly after use.
Unopened calibrators can be used for one year from the date of manufacturing as indicated on the expiration date on the package and bottle labels.
Opened bottles of calibrators can be used for 1 month if stored at 2–8°C.
 
Example Package Insert
Safety Data Sheet
                                                                                            
ASO / RF / CRP Control
Cat. No.: K55C-4M
Type: Control
Kit Composition:
Level 1: Human Serum, 2 x 2 mL, lyophilized
Level 2: Human Serum, 2 x 2 mL, lyophilized
 
Intended Use
The K-ASSAY® ASO / RF / CRP Control is intended to be used as a consistent test sample of known concentrations for monitoring the performance of the K-ASSAY® immunoturbidimetric assays for the following constituents:
Anti-Streptolysin O (ASO)
Rheumatoid Factor, RF (Ver.2)
C-Reactive Protein (CRP)
Wide Range CRP
FOR IN VITRO DIAGNOSTIC USE.
 
Control Preparation
Carefully and slowly remove rubber stopper and let air enter vacuum-sealed bottle.
Carefully add exactly 2 mL purified water (at room temperature) to bottle. DO NOT MIX.
Replace rubber stopper.
Let bottle sit at room temperature for 10 minutes.
Mix by slowly swirling bottle numerous times. DO NOT SHAKE or induce foaming.
Continue to mix until all contents have dissolved completely.
Before each subsequent use, be sure to mix bottle by slowly swirling.
 
Storage and Handling
Store lyophilized and reconstituted controls at 2–8°C. Return all controls to 2–8°C promptly after use.
Unopened controls can be used for one year from the date of manufacturing, as indicated by the expiration date on the package and bottle labels.
Reconstituted controls can be used for 2 weeks if stored at 2–8°C.
Reconstituted controls may also be frozen immediately after reconstitution at –20°C for 2 months and then thawed ONE TIME ONLY.
 
Example Package Insert
Safety Data Sheet