Identity
- Trade Name
- iChem Velocity FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA) 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)" 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)" FDA UDI
- Model / Reference
- Back-Integrated Velocity (NA) FDA UDI
- Description
- 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA) 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)" 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA) "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload" "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)" FDA UDI
Identifiers
- Catalog Number
- 700-7177-001 FDA UDI
- Primary DI / UDI-DI
- 10837461001751 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 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: Urine analyser IVD, laboratory
iChem Velocity by Beckman Coulter Ireland Inc. — 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
- Beckman Coulter Ireland Inc.
Sources (1)
- FDA UDI 92f2c866-f39a-4047-a552-81cdc6888d40 34 fields · synced May 30, 2026