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iQ®200

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter Ireland Inc.

Identity

Trade Name
iQ®200 FDA UDI
Generic Name
Urine sediment IVD, calibrator FDA UDI
Device Name
iQ® Body Fluids Controls-Level I and Level II (NA/INTL) FDA UDI
Model / Reference
iQ® Body Fluids Controls-Level I and Level II (NA/INTL) FDA UDI
Description
iQ® Body Fluids Controls-Level I and Level II (NA/INTL) FDA UDI

Identifiers

Catalog Number
800-3219 FDA UDI
Primary DI / UDI-DI
10837461002345 FDA UDI
510(k) Number
K051706 FDA UDI
FDA Product Code
JPK FDA UDI
GMDN Term
Urine sediment IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.8625 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Urine sediment IVD, calibrator

iQ®200 by Beckman Coulter Ireland Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine sediment IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter Ireland Inc.

Sources (1)

  • FDA UDI 2bd7780f-f227-40ed-9796-468823acef9d 35 fields · synced May 30, 2026