Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Lumipulse G pTau217/B
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio - CL0073

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SET

Device Name: Immunoassay Blood Test For Amyloid Pathology Assessment

Device Class: 2

Physical State: In vitro diagnostic device

Definition: An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Immunoassay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human blood specimens

Regulation Number: 866.5840

Third Party Flag: N

Medical Specialty: IM

Device Id: 00869164000086

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