Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681582

FEI Number

3002807541

Entity Name

IQ PRODUCTS B.V.

City/State/Country

GRONINGEN, NL

Establishment Address

ROZENBURGLAAN 13A, GRONINGEN 9727DL, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IQ PRODUCTS B.V. (Owner Number: 9025233)

Owner / Operator Contact Address

ROZENBURGLAAN 13A, --, GRONINGEN, NL-NOTA 9727 DL, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991650

PMA Number

N/A

All Registered Proprietary Names

CMV BRITE ANTIGENEMIA TEST KIT CMV BRITE TURBO KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIN	Antisera, Conjugated Fluorescent, Cytomegalovirus	Microbiology	Class 2	866.3175	1996-03-22

Official Correspondent

CHRISTINE KEBBEDIES

US Agent Details

Jeremy Harlan Business: CEDARLANE LABORATORIES U.S.A., INC. Email: Jeremy.harlan@cedarlanelabs.com Phone: (336) 5135135

Related Public Records

Same Entity

IQ PRODUCTS B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681582. Last updated year: 2026. Please use registration number 9681582 when referencing this establishment in official correspondence.