CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 CC667

GUDID 00817302022667

LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests

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, 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 ID00817302022667
NIH Device Record Keycd510ead-9dd9-40db-b56d-646bdebe52eb
Commercial Distribution Discontinuation2018-08-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667
Version Model NumberCC667
Catalog NumberCC667
Company DUNS962385787
Company NameCAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
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

Device Dimensions

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Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0
Total Volume19 Milliliter
Total Volume52 Milliliter
Total Volume3 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
Special Storage Condition, SpecifyBetween 0 and 0 *Onboard the SYNCHRON: LDL is stable for 30 days.

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302022667 [Primary]

FDA Product Code

LBRLDL & VLDL PRECIPITATION, HDL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

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