Identity
- Trade Name
- Galileo Neo FDA UDI
- Generic Name
- Immunohaematology/blood bank analyser IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 0064599 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 0064599 FDA UDI
- Primary DI / UDI-DI
- 10888234001041 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Immunohaematology/blood bank analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunohaematology/blood bank analyser IVD
Galileo Neo by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI 7f57b824-c147-46cf-9ab3-368fa253dab9 36 fields · synced May 30, 2026