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Home›USA›MEDTOX DIAGNOSTICS, INC.

MEDTOX DIAGNOSTICS, INC.

USA · Burlington
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
20listed device types
Class I 6Class II 13Class III 0unclassified 1
plus 56 registration records and 22 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
27active device licences
Class II 20Class III 7
33 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States56 registration records, 22 510(k), 0 PMA
Canada27 confirmed, 0 excluded
Manufacturer names merged into this page: MEDTOX DIAGNOSTICS, INC. · MEDTOX Diagnostics, Inc. · MEDTOX DIAGNOSTICS, INC., DBA LABCORP POINT OF CARE
Same-named companies — This database also contains companies with near-identical names: MEDTOX DIAGNOSTICS, INC., DBA LABCORP POINT OF CARE. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Burlington

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11998
11999
22000
72001
22002
22003
12005
12006
22009
22010
12026

FDA listed device types

showing 8 of 20
Radioimmunoassay, Tricyclic Antidepressant Drugs 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Semen Analysis Device 1Enzyme Immunoassay, Cannabinoids 1Thin Layer Chromatography, Methamphetamine 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252684Labcorp Fentanyl Urine Visual Test2026-01-29
USK100951MEDTOX BUPRENORPHINE TEST2010-10-18
USK100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM2010-04-05
CA3049EZ-SCREEN: AMPHETAMINEClass III
CA3050EZ-SCREEN: CANNABINOID/COCAINEClass III
CA3051EZ-SCREEN: PCPClass III

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