Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use.
Pointe Lipoprotein (a) Control Set - L7597-CTL
Device Description
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of lipoprotein A 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: JJX
Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
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: 862.1660
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00811727015594
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