Identity
- Trade Name
- A20 Advanced Automated Osmometer FDA UDI
- Generic Name
- Osmometric analyser IVD FDA UDI
- Device Name
- Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time. FDA UDI
- Model / Reference
- A2O FDA UDI
- Description
- Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time. FDA UDI
Identifiers
- Catalog Number
- A2O FDA UDI
- Primary DI / UDI-DI
- 00816068020641 FDA UDI
- FDA Product Code
- JJM FDA UDI
- GMDN Term
- Osmometric analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2730 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Osmometric analyser IVD
A20 Advanced Automated Osmometer by Advanced Instruments, LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Instruments, LLC
Sources (1)
- FDA UDI 8c621409-6406-4add-96a0-9c959614ad82 35 fields · synced Jun 8, 2026