Home GUDID 00812137010223 Boule Cal
Primary DI 00812137010223
Brand Boule Cal
Company CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model 1 x 3.0mL
Catalog number 501-606
Device description Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material.Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument.
Published 2016-09-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812137010223 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812137010223 00812137010223 812137010223 0812137010223
GMDN Terms# Term, Definition table Term Definition Full blood count IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 048144997 Device count 1 DM exempt true HCT/P true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00812137011848 Albumin Reagent 500 mL 501-397 2016-10-12 00812137012005 LDH Reagent Set R1 x 500mL, R2 x 125mL 501-413 2016-10-12 00812137011855 Alkaline Phosphatase Reagent Set R1 x 500 mL, R2 x 125 mL 501-398 2016-10-12 00812137011886 AST (SGOT) Reagent Set R1 x 500mL, R2 x 125mL 501-401 2016-10-12 00812137011961 Creatinine Reagent Set R1 x 500mL, R2 x 125mL 501-409 2016-10-12 00812137012098 CRP Reagent Set R1 x 50mL, R2 x 50mL 501-435 2016-10-12 00812137012142 CRP Calibrator Set 5 x 2mL 502-154 2016-10-12 00812137012159 CRP Control Set L1 x 3 x 3mL, L2 x 3 x 3mL 502-155 2016-10-12 00812137012197 Multi-Analyte Lipid Control Set L1 x 3mL, L2 x 3mL, L3 x 3mL 502-160 2016-10-12 00812137012111 Chemistry Calibrator Set 10 x 5mL, 1 x 50mL 502-151 2016-10-12 00812137012128 Chemistry Control Level I Set 10 x 5mL 502-152 2016-10-12 00812137012135 Chemistry Control Level II Set 10 x 5mL 502-153 2016-10-12 00001812701208 Triglycerides Reagent 500mL 501-417 2016-10-12 00812137010254 CDS-LTX CONTROL 6 x 16 mL 502-006 2016-09-08 00812137010261 CDS-LTX PRIMER 6 x 16mL 502-007 2016-09-08 00812137011947 Carbon Dioxide Reagent 120mL 501-407 2016-10-12 00812137011916 Urea Nitrogen Reagent Set R1 x 500mL, R2 x 125mL 501-404 2016-10-12 00081213701184 Albumin Reagent 500 mL 501-397 2016-10-12 00812137010216 Boule Con-Diff Tri-Level 6 x 4.5mL 501-605 2016-09-02 00812137010230 Boule Con-Diff Tri-Level 9 x 4.5mL 501-607 2016-09-06
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