FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616

Primary DI
00817302022193
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
BL616
Catalog number
BL616
Device description
HDLD (High Density Lipoprotein Direct) w/ cal 3 x 100 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBRLDL & VLDL PRECIPITATION, HDL
LBSLDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302022193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302022193008173020221938173020221930817302022193

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 Volume2Milliliter
Total Volume3Milliliter
Total Volume25Milliliter

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
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302020182CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224BL-224.BL-224.2016-09-01
00817302020199CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224ST224ST2242016-09-01
00817302020205CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224AU-224AU-2242016-09-01
00817302020212CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224CC224CC2242016-09-01
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CC214CC2142016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214AU-214AU-2142016-09-01
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224DT224DT2242016-10-17
00817302021912CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419BBL419BBL419B2016-09-01
00817302020786CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425BL425BL4252016-09-01
00817302020809CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425AU-425AU-4252016-09-01
00817302020816CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425DT425DT4252016-09-01
00817302020847CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424AU-424AU-4242016-09-01
00817302021066CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412AU-412AU-4122016-09-01
00817302021127CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT AU-417AU-417AU-4172016-09-01
00817302021189CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418AU-418AU-4182016-09-01
00817302021257CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT AU-413AU-413AU-4132016-09-01
00817302021349CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421BL421BL4212016-09-01
00817302021370CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421AU-421AU-4212016-09-01
00817302021455CAROLINA LIQUID CHEMISTRIES CORP.® METD RGT. KIT AU-415AU-415AU-4152016-09-01
00817302021516CAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT AU-427AU-427AU-4272016-09-01

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