FDA.reportPublic FDA data

CDS Hematology Calibrator

Primary DI
00812137010360
Brand
CDS Hematology Calibrator
Company
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model
1x3.0mL
Catalog number
502-040
Device description
CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers.CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRZCalibrator For Hemoglobin And Hematocrit Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812137010360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812137010360008121370103608121370103600812137010360

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, calibratorA 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
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004533328quality@cdsolinc.com

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 DIBrandModelCatalogPublished
00812137011848Albumin Reagent500 mL501-3972016-10-12
00812137012005LDH Reagent SetR1 x 500mL, R2 x 125mL501-4132016-10-12
00812137011855Alkaline Phosphatase Reagent SetR1 x 500 mL, R2 x 125 mL501-3982016-10-12
00812137011886AST (SGOT) Reagent SetR1 x 500mL, R2 x 125mL501-4012016-10-12
00812137011961Creatinine Reagent SetR1 x 500mL, R2 x 125mL501-4092016-10-12
00812137012098CRP Reagent SetR1 x 50mL, R2 x 50mL501-4352016-10-12
00812137012142CRP Calibrator Set5 x 2mL502-1542016-10-12
00812137012159CRP Control SetL1 x 3 x 3mL, L2 x 3 x 3mL502-1552016-10-12
00812137012197Multi-Analyte Lipid Control SetL1 x 3mL, L2 x 3mL, L3 x 3mL502-1602016-10-12
00812137012111Chemistry Calibrator Set10 x 5mL, 1 x 50mL502-1512016-10-12
00812137012128Chemistry Control Level I Set10 x 5mL502-1522016-10-12
00812137012135Chemistry Control Level II Set10 x 5mL502-1532016-10-12
00001812701208Triglycerides Reagent500mL501-4172016-10-12
00812137010254CDS-LTX CONTROL6 x 16 mL502-0062016-09-08
00812137010261CDS-LTX PRIMER6 x 16mL502-0072016-09-08
00812137011947Carbon Dioxide Reagent120mL501-4072016-10-12
00812137011916Urea Nitrogen Reagent SetR1 x 500mL, R2 x 125mL501-4042016-10-12
00081213701184Albumin Reagent500 mL501-3972016-10-12
00812137010216Boule Con-Diff Tri-Level6 x 4.5mL501-6052016-09-02
00812137010223Boule Cal1 x 3.0mL501-6062016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
04015630921096Cfas HbA1cRoche Diagnostics GmbHKRZ2016-09-20
20844509000246Cal-ChexSTRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRZ2016-09-16
00847817000324VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
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00847817013966VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
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00812137010223Boule CalCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-06
00812137010421CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00380740017071CELL-DYNABBOTT LABORATORIESKRZ2016-06-06
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