Identity
- Trade Name
- EUROArrayProcessor reagent tray set FDA UDI
- Generic Name
- General laboratory assay tray FDA UDI
- Model / Reference
- ZM 9999-0640-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016148265 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- General laboratory assay tray FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General laboratory assay tray
EUROArrayProcessor reagent tray set by EUROIMMUN Medizinische Labordiagnostika AG — 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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 4d1bce1e-6376-45b6-ad7e-60ca0f3bb80d 32 fields · synced May 29, 2026