Galileo Neo - The Galileo Neo (NEO) is a - IMMUCOR, INC.

Duns Number:061446282

Device Description: The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohe The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can then be subjected to confirmation using a licensed method.

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More Product Details

Catalog Number

0064599

Brand Name

Galileo Neo

Version/Model Number

0064599

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KSZ

Product Code Name

System, Test, Automated Blood Grouping And Antibody

Device Record Status

Public Device Record Key

7f57b824-c147-46cf-9ab3-368fa253dab9

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

April 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUCOR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 58
U Unclassified 3