Consulting Wallah › Device Explorer › IVD & laboratory › Multiple drugs of abuse IVD, kit, rapid ICT, clini
Device Explorer · FDA GUDID · GMDN 46994

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, us

US‑registered devices6,269in commercial distribution
Companies74labelers on GUDID
Single‑use100%of device records
Sterile1%labelled sterile
Prescription39%Rx‑only share
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Share of device records

American Screening, L.L.C.1,50024%
Advin Biotech, Inc.4347%
Instant Technologies, Inc.3686%
Healgen Scientific Limited Liability Company3586%
Wondfo Usa Co., Ltd.3215%
Express Diagnostic Int'L, Inc.2534%
Medical Disposables Corp2484%
Rapid Diagnostics Inc2284%

Top labelers

CompanyDevicesShare
American Screening, L.L.C.1,50024%
Advin Biotech, Inc.4347%
Instant Technologies, Inc.3686%
Healgen Scientific Limited Liability Company3586%
Wondfo Usa Co., Ltd.3215%
Express Diagnostic Int'L, Inc.2534%
Medical Disposables Corp2484%
Rapid Diagnostics Inc2284%
W.H.P.M. Inc.2183%
Micro Distributing, L.C1853%
Hangzhou Alltest Biotech Co., Ltd.1843%
Alere San Diego, Inc.1673%

Company = labeler of record on GUDID. 74 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Pocguide Multi-Drug Test Panel OTCPocguide Multi-Drug Test PanelPocguide Multi-Drug Test Cup OTCPocguide Multi-Drug Test CupS-Trust SE Oral Fluid Multi-Drug Test Cup(ColloiU-Catch XR Multi-Drug Test Cup(Colloidal Gold)U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)BioTekeExploro Highly Sensitive Urine Drug Test (12-PanExploro Highly Sensitive Urine Drug Test (14-PanExploro Highly Sensitive Urine Drug Test (5-PaneT Testahead Multi-Drug Urine Test Dip CardExploro 7-Panel Urine Drug TestExploro Highly Sensitive 5-Panel Urine Drug Test7-Panel Urine Drug TestU-Catch

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

FDA product codes

CodeNameDevices
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites4,163
DJGEnzyme Immunoassay, Opiates4,110
LDJEnzyme Immunoassay, Cannabinoids3,651
DKZEnzyme Immunoassay, Amphetamine3,563
JXMEnzyme Immunoassay, Benzodiazepine3,079
LCMEnzyme Immunoassay, Phencyclidine2,444

GMDN & GCC registration

  • GMDN code 46994 · non‑implantable
  • Single‑use 100% · sterile 1% · Rx‑only 39% · OTC 41%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 324Height (Millimeter) · 38

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

How many multiple drugs of abuse ivd, kit, rapid ict, clinical products are registered in the US?

6,269 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple drugs of abuse IVD, kit, rapid ICT, clinical", from 74 companies. The largest labeler is American Screening, L.L.C. with 24% of records.

Which FDA product codes apply?

DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), DJG (Enzyme Immunoassay, Opiates), LDJ (Enzyme Immunoassay, Cannabinoids), DKZ (Enzyme Immunoassay, Amphetamine)

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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