Identity
- Trade Name
- Galileo Echo FDA UDI
- Generic Name
- Immunohaematology/blood bank analyser IVD FDA UDI
- Device Name
- The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. FDA UDI
- Model / Reference
- 0087000 FDA UDI
- Description
- The Galileo Echo is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Galileo Echo automates test processing, result interpretation, and data management functions. The Galileo Echo is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. FDA UDI
Identifiers
- Catalog Number
- 0087000 FDA UDI
- Primary DI / UDI-DI
- 10888234001584 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 Echo by Immucor, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
BK070016 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (2)
- FDA UDI 456fae1e-e33f-4b7c-8250-eea0a084be81 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026