Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005948789

FEI Number

3005948789

Entity Name

INVITRON

City/State/Country

Monmouth Monmouthshire, GB

Establishment Address

Wyastone Business Park, Wyastone Leys, Monmouth Monmouthshire NP25 3SR, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Invitron (Owner Number: 10028030)

Owner / Operator Contact Address

Wyastone Business Park, Wyastone Leys, Monmouth, GB-MON NP25 3SR, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV2-101E Insulin ELISA Kit IV2-001 MLT Insulin Kit IV2-004 MLT C-Peptide Kit IV2-102E Intact Proinsulin ELSIA Kit IV2-103E Total Proinsulin ELISA Kit IV2-002 MLT Intact Proinsulin Kit IV2-104E C-Peptide ELISA IV2-003 MLT Total Proinsulin Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2008-12-23
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2008-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Invitron

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 3005948789. Last updated year: 2026. Please use registration number 3005948789 when referencing this establishment in official correspondence.