Randox Teoranta

FDA Device Registration & Listing · Dungloe Donegal, IE · Registration 3009473156

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009473156
FEI Number
3009473156
Entity Name
Randox Teoranta
City/State/Country
Dungloe Donegal, IE
Establishment Address
Meenmore, Dungloe Donegal F94 TV06, IE
Establishment Type(s)
Foreign Private Label Distributor
Owner / Operator
RANDOX LABORATORIES, LTD. (Owner Number: 8020890)
Owner / Operator Contact Address
55 DIAMOND RD., --, CRUMLIN, CO.ANTRIM, GB-NOTA BT29 4QY, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Evidence MultiSTAT DOA Urine Multiplex Evidence MultiSTAT CHOLRIDE ELECTRODE (I.S.E. Cl) SODIUM ELECTRODE (I.S.E. Na) POTASSIUM ELECTRODE (I.S.E. K)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2024-09-11
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2024-09-11
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2024-09-11
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2024-09-11
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2024-09-11
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2023-09-20
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2023-09-20
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2023-09-20

Official Correspondent

Karena Shaw

US Agent Details

John Naizer Business: RANDOX LABORATORIES-US, LTD Email: John.Naizer@randox.com Phone: (304) 7282890

Related Public Records

Same Entity

RANDOX LABORATORIES, LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2086993 RANDOX LABORATORIES-US, LTD Kearneysville, WV, US
3014607865 RANDOX LABORATORIES LIMITED ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB
3004493545 RANDOX LABORATORIES LIMITED CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153050 Co-Innovation Biotech Co., Ltd. Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 2016-04-26
K151478 Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup 2015-07-01
K150179 Guangzhou Wondfo Biotech Co., Ltd. CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25
K112310 Guangzhou Wondfo Biotech Co., Ltd. WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08
K093175 Guangzhou Wondfo Biotech Co., Ltd. WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 2010-08-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2013 Alere San Diego, Inc. 2
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software
Z-0010-06 Abbott Laboratories, Inc 1
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

Similar Registrations

Registration Number Establishment Name Location
3004987297 UCP BIOSCIENCES, INC. Milpitas, CA, US
3010800486 Premier Biotech, LLC Minneapolis, MN, US
3010939897 Microgenics Corporation Fremont, CA, US
3005360469 ACRO BIOTECH Inc. Montclair, CA, US
2050010 BECKMAN COULTER, INC. CARLSBAD, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009473156. Last updated year: 2026. Please use registration number 3009473156 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.