CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 DT661

GUDID 00817302024487

LDL Cholesterol Direct (LDLD) w/ Calibrator

CAROLINA LIQUID CHEMISTRIES CORPORATION

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Primary Device ID00817302024487
NIH Device Record Key467da600-5dda-41ee-ab52-26b0fdf7b07a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661
Version Model NumberDT661
Catalog NumberDT661
Company DUNS962385787
Company NameCAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com
Phone+1(800)471-7272
EmailContactSales@CarolinaChemistries.com

Device Dimensions

Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter
Device Size Text, specify0
Total Volume26 Milliliter
Total Volume3 Milliliter
Total Volume64 Milliliter

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
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
GS100817302024487 [Primary]

FDA Product Code

MRRSYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

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