FDA.reportPublic FDA data

Triglycerides Reagent

Primary DI
00001812701208
Brand
Triglycerides Reagent
Company
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model
500mL
Catalog number
501-417
Device description
For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism.
Published
2016-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00001812701208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00001812701208000018127012080018127012080001812701208

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of triglycerides in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004533328quality@cdsolinc.com

Regulatory Flags#

DUNS number
048144997
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812137011848Albumin Reagent500 mL501-3972016-10-12
00812137012005LDH Reagent SetR1 x 500mL, R2 x 125mL501-4132016-10-12
00812137011855Alkaline Phosphatase Reagent SetR1 x 500 mL, R2 x 125 mL501-3982016-10-12
00812137011886AST (SGOT) Reagent SetR1 x 500mL, R2 x 125mL501-4012016-10-12
00812137011961Creatinine Reagent SetR1 x 500mL, R2 x 125mL501-4092016-10-12
00812137012098CRP Reagent SetR1 x 50mL, R2 x 50mL501-4352016-10-12
00812137012142CRP Calibrator Set5 x 2mL502-1542016-10-12
00812137012159CRP Control SetL1 x 3 x 3mL, L2 x 3 x 3mL502-1552016-10-12
00812137012197Multi-Analyte Lipid Control SetL1 x 3mL, L2 x 3mL, L3 x 3mL502-1602016-10-12
00812137012111Chemistry Calibrator Set10 x 5mL, 1 x 50mL502-1512016-10-12
00812137012128Chemistry Control Level I Set10 x 5mL502-1522016-10-12
00812137012135Chemistry Control Level II Set10 x 5mL502-1532016-10-12
00812137010254CDS-LTX CONTROL6 x 16 mL502-0062016-09-08
00812137010261CDS-LTX PRIMER6 x 16mL502-0072016-09-08
00812137011947Carbon Dioxide Reagent120mL501-4072016-10-12
00812137011916Urea Nitrogen Reagent SetR1 x 500mL, R2 x 125mL501-4042016-10-12
00081213701184Albumin Reagent500 mL501-3972016-10-12
00812137010216Boule Con-Diff Tri-Level6 x 4.5mL501-6052016-09-02
00812137010223Boule Cal1 x 3.0mL501-6062016-09-06
00812137010230Boule Con-Diff Tri-Level9 x 4.5mL501-6072016-09-06

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Primary DI, Brand, Company table
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10673486002225Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
10673486002232Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
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