iQ200

FDA UDI

Class I (US FDA UDI)

by Beckman Coulter Ireland Inc.

Identity

Trade Name: iQ200 FDA UDI
Generic Name: Urine analyser IVD, laboratory FDA UDI
Device Name: "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);" "iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3933 iQ®200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)" FDA UDI
Model / Reference: Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint P FDA UDI
Description: "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);" "iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)" "iQ200 Sprint 2008 Tested; 800-3933 iQ®200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)" FDA UDI

Identifiers

Catalog Number: 700-3325 FDA UDI
Primary DI / UDI-DI: 10837461001256 FDA UDI
510(k) Number: K022774 FDA UDI
FDA Product Code: KQO FDA UDI
LKM FDA UDI
GMDN Term: Urine analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2900 FDA UDI
864.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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 fbfa60cb-c45f-40c9-82d2-b9c58d4f25af 35 fields · synced May 30, 2026