Chemistry Calibrator Set 502-151

GUDID 00812137012111

The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Multiple clinical chemistry analyte IVD, calibrator
Primary Device ID00812137012111
NIH Device Record Key31d2cd5e-4e35-45cd-b3d6-50721f0a7d1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameChemistry Calibrator Set
Version Model Number10 x 5mL, 1 x 50mL
Catalog Number502-151
Company DUNS048144997
Company NameCLINICAL DIAGNOSTIC SOLUTIONS, INC.
Device Count11
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com
Phone8004533328
Emailquality@cdsolinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812137012111 [Primary]
GS100812137012401 [Unit of Use]

FDA Product Code

JIXCalibrator, Multi-Analyte Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-12

Devices Manufactured by CLINICAL DIAGNOSTIC SOLUTIONS, INC.

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00812137010254 - CDS-LTX CONTROL2018-07-06 CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S in
00812137010261 - CDS-LTX PRIMER2018-07-06 CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments pr
00812137011947 - Carbon Dioxide Reagent2018-06-11 For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
00812137011916 - Urea Nitrogen Reagent Set2018-04-17 For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen
00081213701184 - Albumin Reagent2018-03-29 For the quantitative determination of Albumin in serum.
00812137010216 - Boule Con-Diff Tri-Level2018-03-29 For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff T

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