Identity
- Trade Name
- iQ200 FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)" FDA UDI
- Model / Reference
- Select/Elite Pro (NA) FDA UDI
- Description
- "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)" "iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)" FDA UDI
Identifiers
- Catalog Number
- 700-3347/700-3375 FDA UDI
- Primary DI / UDI-DI
- 10837461001317 FDA UDI
- 510(k) Number
- K022774 FDA UDI
- FDA Product Code
- KQO FDA UDILKM FDA UDI
- GMDN Term
- Urine analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI864.5200 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
iQ200 by Beckman Coulter Ireland Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K022774 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
Sources (2)
- FDA UDI c5d69369-21f5-41bb-8766-5b3dc26cfd9e 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026