Consulting Wallah › Device Explorer › IVD & laboratory › Multiple therapeutic drugs/drugs of abuse IVD, cal
Device Explorer · FDA GUDID · GMDN 55455

Multiple therapeutic drugs/drugs of abuse IVD, calibrator

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.

US‑registered devices250in commercial distribution
Companies4labelers on GUDID
Single‑use98%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

American Bio Medica Corporation24498%
Ark Diagnostics Inc31%
Chromsystems Instruments + Chemicals Gmbh21%
Ortho-Clinical Diagnostics, Inc.10%

Top labelers

CompanyDevicesShare
American Bio Medica Corporation24498%
Ark Diagnostics Inc31%
Chromsystems Instruments + Chemicals Gmbh21%
Ortho-Clinical Diagnostics, Inc.10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Urine Calibrator SetARK™ Zopiclone Cutoff CalibratorARK™ Zopiclone Negative CalibratorARK™ Zopiclone CalibratorVITROSRapid ONERTCII 2nd gen.INCUPRDSRTCII 1st gen.Rapid TOX

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LCMEnzyme Immunoassay, Phencyclidine266
DJGEnzyme Immunoassay, Opiates266
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites266
JXMEnzyme Immunoassay, Benzodiazepine266
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressan222
DJREnzyme Immunoassay, Methadone191

GMDN & GCC registration

  • GMDN code 55455 · non‑implantable
  • Single‑use 98% · sterile 0% · Rx‑only 99% · OTC 6%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 1

Use these as the dimensions to specify in a tender line.

How many multiple therapeutic drugs/drugs of abuse ivd, calibrator products are registered in the US?

250 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple therapeutic drugs/drugs of abuse IVD, calibrator", from 4 companies. The largest labeler is American Bio Medica Corporation with 98% of records.

Which FDA product codes apply?

LCM (Enzyme Immunoassay, Phencyclidine), DJG (Enzyme Immunoassay, Opiates), DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), JXM (Enzyme Immunoassay, Benzodiazepine)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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