Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Immunohaematology/blood bank analyser IVD FDA UDI
- Device Name
- ORTHO VISION™ Max Analyzer (MTS) FDA UDI
- Model / Reference
- 6904577 FDA UDI
- Description
- ORTHO VISION™ Max Analyzer (MTS) FDA UDI
Identifiers
- Catalog Number
- 6904576 FDA UDI
- Primary DI / UDI-DI
- 10758750012824 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Immunohaematology/blood bank analyser IVD
Ortho by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohaematology/blood bank analyser IVD.
- TANGO infinity — Bio-Rad Medical Diagnostics GmbH · Class II
- Galileo Echo — IMMUCOR, INC. · Class II
- TANGO optimo — Bio-Rad Medical Diagnostics GmbH · Class II
- NEO Iris — IMMUCOR, INC. · Class II
- IH-1000 — Bio-Rad Medical Diagnostics GmbH · Class II
- Galileo Neo — IMMUCOR, INC. · Class II
- IH-500 — Bio-Rad Medical Diagnostics GmbH · Class II
- ORTHO — Ortho-Clinical Diagnostics · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI fb6628ce-37e7-43a3-b722-32f167e1b3de 35 fields · synced May 31, 2026