Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014271897

FEI Number

3014271897

Entity Name

SANQUIN REAGENTS B.V.

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Plesmanlaan125, Amsterdam Noord-Holland 1066CX, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sanquin Reagents B.V. (Owner Number: 10056688)

Owner / Operator Contact Address

Plesmanlaan125, Amsterdam, NL-NH 1066CX, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N Latex FLC lambda N FLC Control SL1 N FLC Supplementary Reagent N Latex FLC kappa N FLC Control SL2 N FLC Standard SL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-01-16
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-01-16

Official Correspondent

Marina Kalli

US Agent Details

Daryl Wisdahl Business: MedEnvoy Global Inc. Email: usagent@medenvoyglobal.com Phone: (512) 2560570

Related Public Records

Same Entity

Sanquin Reagents B.V.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822676	Amico Lab, Inc.	FITC ANTISERA TO HUMAN IGG	1982-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014271897. Last updated year: 2026. Please use registration number 3014271897 when referencing this establishment in official correspondence.