FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616

Primary DI
00817302022209
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
AU-616
Catalog number
AU-616
Device description
HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 tests
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBRLDL & VLDL PRECIPITATION, HDL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302022209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302022209008173020222098173020222090817302022209

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume3Milliliter
Total Volume20Milliliter
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 30 days
Special Storage Condition, Specify00Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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 DIBrandModelCatalogPublished
00817302022353Carolina Liquid Chemistries Corp. Basic Multi-Drug Control SetCC4492023-03-27
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCLCE11062023-03-10
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCLCF650252023-03-10
00817302024678CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445CC445CC4452022-12-03
00817302024654Caldon Biotech Aldolase ReagentCALD-015CALD-0152022-11-30
00817302024661Caldon Biotech Serum Aldolase ControlsCOAL-015COAL-0152022-11-30
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240AU-240AU-2402022-10-18
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220AU-220AU-2202022-08-19
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218AU-240AU-2402022-08-19
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618AU-618AU-6182022-08-19
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621AU-621AU-6212022-08-19
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661AU-661AU-6612022-08-19
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209BL209BL2092022-08-19
00817302024166CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211BL211BL2112022-08-19
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212BL212BL2122022-08-19
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218BL218BL2182022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.LBR2026-03-09
10682607690081Mission Cholesterol Control SolutionAcon Laboratories, Inc.LBR2026-03-09
00850053916175IDG/SanzayIDG/SANZAY CorporationLBR2024-01-12
10673486001907Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-MatrixTECO DIAGNOSTICSLBR2023-11-20
10673486001938Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-20
10673486001884Teco Diagnostics HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
10673486001891Teco Diagnostics Direct HDL Cholesterol Reagent SetTECO DIAGNOSTICSLBR2023-11-10
10381934747016Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.LBR2023-03-25
04987481164536L-Type LDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
04987481164543L-Type LDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2021-06-01
10381934722013CardioChek Plus Home Lipid Panel Self-Test Strip 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.LBR2021-02-08
04015630934584LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2021-02-08
04015630934591LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2021-02-08
00811727016171Pointe autoHDL Cholesterol ReagentPOINTE SCIENTIFIC, INC.LBR2021-01-30
03610230007044Yumizen C1200 HDL DirectHORIBA ABX SASLBR2020-11-02
04987481164581L-Type HDL-C Reagent 1FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2020-10-23
04987481164598L-Type HDL-C Reagent 2FUJIFILM WAKO PURE CHEMICAL CORPORATIONLBR2020-10-23
03610230007099Yumizen C1200 LDL DirectHORIBA ABX SASLBR2020-08-28
00811727015860Pointe autoHDL for the BS480POINTE SCIENTIFIC, INC.LBR2020-05-28
10758750009527VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBR2020-04-18
07613336121375LDL-Cholesterol Gen.3Roche Diagnostics GmbHLBR2020-03-05
05055273201161HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBR2019-06-03
00850006113064Curo L5KPI HEALTHCARE, INC.LBR2019-04-26
00817302022667CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667CAROLINA LIQUID CHEMISTRIES CORPORATIONLBR2018-08-27
00380740129972AlinityABBOTT LABORATORIESLBR2018-07-11
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBR2018-05-18
05060500091996Synermed®INFRARED LABORATORY SYSTEMS LLCLBR2017-02-28
20304040037731CardioChekHENRY SCHEIN, INC.LBR2017-01-05
10304040037741CardioChekHENRY SCHEIN, INC.LBR2017-01-05