Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017889386

FEI Number

3017889386

Entity Name

PRETECT AS

City/State/Country

Klokkarstua Akershus, NO

Establishment Address

Ustadhagan 8, Klokkarstua Akershus N-3490, NO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PreTect AS (Owner Number: 10079687)

Owner / Operator Contact Address

Ustadhagan 8, Klokkarstua, NO-NOTA N-3490, NO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lysis buffers Pretect X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2020-12-18

Official Correspondent

Bente Marie Falang

US Agent Details

Frank Melendez Business: Mel-mont Medical, Inc Email: f.melendez@xytotest.com Phone: (305) 3356162

Related Public Records

Same Entity

PreTect AS

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009189893	Agilent Technologies Inc.	Cedar Creek, TX, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
1831638	RICHARD-ALLAN SCIENTIFIC LLC	KALAMAZOO, MI, US
1419699	E K INDUSTRIES, INC.	JOLIET, IL, US
3039353646	PHADIA AB	Uppsala, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017889386. Last updated year: 2026. Please use registration number 3017889386 when referencing this establishment in official correspondence.