LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORP.® LDL DIRECT REAGENT CC667 - CC667
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
- LDL Reagent is stable until the date of expiration on the kit when stored tightly capped at 2-8°C.
- Onboard the SYNCHRON: LDL is stable for 30 days.
- 8.00
- 2.00
Device Sizes
- Total Volume: 19 Milliliter
- Total Volume: 52 Milliliter
- Total Volume: 3 Milliliter
- Kit contains 2 filled reagent cartridges 1 filled HDL/LDL Calibrator bottle 2 package inserts with LDL 1 and LDL 2 User Defined Parameters printed on the back, and 1 HDL/LDL Calibrator package insert
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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
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: 00817302022667
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