Eu Ivdr
Eu Ivd Class A
On The Market
🇺🇸 United States
Piccolo Xpress
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- EABA11000000EI1
- Basic UDI-DI Code
- ++EABA11000000EI5D
- Reference
- 1100-0000EI
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Abaxis, Inc.
Additional Description
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. Applicable to Italian pharmacies only: This product may be used for near-patient-testing in Italian pharmacies with Piccolo EI Reagent Discs. When used in a pharmacy, do not make a decision of medical relevance without consulting a medical practitioner. See a doctor for all out-of-range results.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201010101 | CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) |
Available In Countries
🇮🇹 Italy
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