Salient Characteristics_LumipulseG1200_11_7_22v2.pdf

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6640--Lumipulse Immunoassay System Nazanin Kreiner
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36C26023Q0412
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Brand Name or Equal Worksheet (“Salient Characteristics”)

1/26/2023

Brand Name Item: Lumipulse G1200 Instrument Essential/significant physical, functional, or performance characteristics.

We need an *FDA approved* instrument to measure (in small samples of human spinal fluid *and* plasma) the following molecules (as part of research into various neurodegenerative conditions, such as Alzheimer’s Disease and concussions):

• Beta-amyloid 1-40 (aka Abeta 40)

• Beta-amyloid 1-42 (aka Abeta 42)

• Ptau 181

• Total tau

• Neurofibrillary Light Chain (NFL) protein

We also need an instrument that can produce CSF amyloid ratio tests (most importantly Abeta 42/Abeta 40 ratio in CSF) that are *FDA approved*.

In addition, we need to have an instrument with

• a throughput of 120 test per hour

• sample capacity of 100 samples on board at once

• capability of adding and replacing reagents as needed, without test interruption

• no plumbing required

• refrigeration on-board the instrument

1) Complete generic identification – Chemiluminescent Enzyme Immunoassay System for measuring the following molecules related to neurodegenerative disease: beta-amyloid 1-42 and 1-40, ptau 181 and total tau in human spinal fluid and blood

2) Applicable model/make/catalog number – Lumipulse G1200

3) Manufacturer name – Fujirebio

File details come from the government source that posted it. Updated .