Reagent for the calibration of Pointe Scientific’s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
1 x 3ml
Pointe Scientific, Inc. - H7545-CAL
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
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
Device Identifiers
Device Id: 00811727011411
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