CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616 DT616

GUDID 00817302023060

HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Primary Device ID00817302023060
NIH Device Record Key4341145c-c8e3-46fd-adc6-4c374396c1be
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616
Version Model NumberDT616
Catalog NumberDT616
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

Device Size Text, specify0
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Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0
Total Volume63 Milliliter
Total Volume12 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302023060 [Primary]

FDA Product Code

LBSLDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

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 Date2016-10-17

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