Identity
- Trade Name
- CELLTRACKS ANALYZER II FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- CellTracks Analyzer II - Refurbished FDA UDI
- Model / Reference
- 9555R FDA UDI
- Description
- CellTracks Analyzer II - Refurbished FDA UDI
Identifiers
- Catalog Number
- 9555R FDA UDI
- Primary DI / UDI-DI
- 10888385000627 FDA UDI
- FDA Product Code
- NQI FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6020 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Celltracks Analyzer Ii by Menarini Silicon Biosystems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · 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 |
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Manufacturer
- Manufacturer
- Menarini Silicon Biosystems Inc.
Sources (1)
- FDA UDI ddd1ea87-a56d-49df-b7b2-8e905f85d9a6 36 fields · synced May 31, 2026