DEVICE: LDL Cholesterol Reagent Set (00812137012074)
Device Identifier (DI) Information
LDL Cholesterol Reagent Set
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution
501-420
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution
501-420
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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53409 | Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of dense low density lipoprotein (DLDL) cholesterol lipid in a clinical specimen, using a mass spectrometry method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LBR | Ldl & Vldl Precipitation, Hdl |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e589da2e-e125-48e0-add2-f8e08c9d7678
March 29, 2018
2
October 12, 2016
March 29, 2018
2
October 12, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00812137012340
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004533328
quality@cdsolinc.com
quality@cdsolinc.com