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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
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
iQ®200 Body Fluids Module (CD only) FDA UDI
Model / Reference
Body Fluids Module FDA UDI
Description
iQ®200 Body Fluids Module (CD only) FDA UDI

Identifiers

Catalog Number
800-3704 FDA UDI
Primary DI / UDI-DI
10837461002475 FDA UDI
510(k) Number
K050235 FDA UDI
FDA Product Code
GKL FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5200 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: Laboratory instrument/analyser application software IVD

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

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

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 8103f61d-c534-4276-96f9-ee6e14572709 35 fields · synced May 30, 2026