HDLD W/CALIBRATOR, 2 X 200 tests
CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 - CC615
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.
Environmental Conditions
- Reagent is stable when stored at 2-8° C until expiration date
- Reagent is stable on board a clinical analyzer for 30 days when stored at 2 to 8°C
- 8.00
- 2.00
Device Sizes
- Kit contains 2 reagent cartridges with R1 and R2, 1 cal 3, 1 calibrator package insert, 1 reagent package insert and 1 user defined parameters
- Total Volume: 20 Milliliter
- Total Volume: 60 Milliliter
- Total Volume: 3 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LBS
Device Name: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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
Code: LBR
Device Name: Ldl & Vldl Precipitation, Hdl
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: 00817302022216
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