LDL Cholesterol Direct (LDLD) w/ Calibrator
CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661 - DT661
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- Kit contains 3 R1 bottles 3 R2 bottles and 1 calibrator
- Total Volume: 26 Milliliter
- Total Volume: 3 Milliliter
- Total Volume: 64 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MRR
Device Name: System, Test, Low Density, Lipoprotein
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.1475
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00817302024487
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A