CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661 AU-661

GUDID 00817302024142

LDL Cholesterol Reagent (LDL) 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 ID	00817302024142
NIH Device Record Key	d63937ca-aa1b-42a4-95f4-ebc1b6d2f562
Commercial Distribution Status	In Commercial Distribution
Brand Name	CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661
Version Model Number	AU-661
Catalog Number	AU-661
Company DUNS	962385787
Company Name	CAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter
Device Size Text, specify	0
Total Volume	60 Milliliter
Total Volume	21 Milliliter
Total Volume	3 Milliliter

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302024142 [Primary]

FDA Product Code

MRR	SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-08-29
Device Publish Date	2022-08-19

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