Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
Pointe Lp(a) Reagent - 16-L7597-160

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DFC

Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.5600

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00811727016225

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