Identity
- Trade Name
- iQ200 FDA UDI
- Generic Name
- Urine analyser IVD, laboratory FDA UDI
- Device Name
- "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008 Tested; 800-3051 iQ®200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)" FDA UDI
- Model / Reference
- Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA) FDA UDI
- Description
- "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008 Tested; 800-3051 iQ®200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)" FDA UDI
Identifiers
- Catalog Number
- 700-3345 FDA UDI
- Primary DI / UDI-DI
- 10837461001300 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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022774 also covers:
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 dee5faf1-8cd0-4626-9ed4-b6003078018c 35 fields · synced Jun 6, 2026