HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616 - DT616
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
- 8.00
- 2.00
Device Sizes
- Total Volume: 63 Milliliter
- Total Volume: 12 Milliliter
- Kit contains 4 R1 bottles, 4 R2 bottles, calibrator, 1 reagent package insert and 1 calibrator package insert
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: 00817302023060
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