Home GUDID 00817302020465 CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909
Primary DI 00817302020465
Brand CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909
Company CAROLINA LIQUID CHEMISTRIES CORPORATION
Model CC909
Catalog number CC909
Device description Cal Level 2 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6 x 25 mL
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817302020465 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 00817302020465 00817302020465 817302020465 0817302020465
GMDN Terms# Term, Definition table Term Definition Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Total Volume 25 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 After opening, the calibrators are stable for 30 days at room temperature (18 - 25°C) or to their expiration date when stored between 2 - 8° and protected from contamination. Special Storage Condition, Specify 0 0 Unopened Reagent is stable when stored at 2-8° C until expiration date Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 962385787 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00817302022353 Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set CC449 2023-03-27 00817302022339 Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN CLCE1106 2023-03-10 00817302022346 Carolina Liquid Chemistries Corp. Fentanyl Detection Kit CLCF65025 2023-03-10 00817302024678 CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445 CC445 CC445 2022-12-03 00817302024654 Caldon Biotech Aldolase Reagent CALD-015 CALD-015 2022-11-30 00817302024661 Caldon Biotech Serum Aldolase Controls COAL-015 COAL-015 2022-11-30 00817302024647 CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240 AU-240 AU-240 2022-10-18 00817302024104 CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220 AU-220 AU-220 2022-08-19 00817302024111 CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218 AU-240 AU-240 2022-08-19 00817302024128 CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618 AU-618 AU-618 2022-08-19 00817302024135 CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621 AU-621 AU-621 2022-08-19 00817302024142 CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661 AU-661 AU-661 2022-08-19 00817302024159 CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209 BL209 BL209 2022-08-19 00817302024166 CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211 BL211 BL211 2022-08-19 00817302024173 CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212 BL212 BL212 2022-08-19 00817302024180 CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213 BL213 BL213 2022-08-19 00817302024197 CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218 BL218 BL218 2022-08-19 00817302024203 CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220 BL220 BL220 2022-08-19 00817302024210 CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240 BL240 BL240 2022-08-19 00817302024227 CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661 BL661 BL661 2022-08-19
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