Consulting Wallah › Device Explorer › IVD & laboratory › Amphetamine/methamphetamine group IVD, kit, rapid
Device Explorer · FDA GUDID · GMDN 55489

Amphetamine/methamphetamine group 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 belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA),

US‑registered devices52in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile6%labelled sterile
Prescription46%Rx‑only share
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Share of device records

Ucp Biosciences, Inc.1529%
Confirm Biosciences, Inc.1019%
Hangzhou Alltest Biotech Co., Ltd.612%
Cliawaived, Inc.36%
Alfa Scientific Designs, Inc.36%
Idun Solutions Llc24%
Siemens Healthcare Diagnostics Inc.24%
Emery Enterprises Inc24%

Top labelers

CompanyDevicesShare
Ucp Biosciences, Inc.1529%
Confirm Biosciences, Inc.1019%
Hangzhou Alltest Biotech Co., Ltd.612%
Cliawaived, Inc.36%
Alfa Scientific Designs, Inc.36%
Idun Solutions Llc24%
Siemens Healthcare Diagnostics Inc.24%
Emery Enterprises Inc24%
Instant Technologies, Inc.24%
Express Diagnostic Int'L, Inc.24%
W.H.P.M. Inc.12%
Woonsocket Prescription Center, Incorporated12%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Alltest MDMA500 Home Rapid Test Panel (Urine)Alltest MDMA500 Home Rapid Test Dipstick (Urine)Alltest MDMA500 Rapid Test Panel (Urine)-CLIA WaAlltest MDMA500 Rapid Test Dipstick(Urine)-CLIA Alltest MDMA500 Rapid Test Dipstick (Urine)Alltest MDMA500 Rapid Test Panel (Urine)Healgen (Private Label) - 264Healgen (Private Label) - 254Healgen (Private Label) - 3104Healgen (Private Label) - 3104CHealgen (Private Label) - 8104CHealgen (Private Label) - 6125Healgen (Private Label) - 194N/MDrugConfirmHealgen (Private Label) - 242

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

FDA product codes

CodeNameDevices
DJCThin Layer Chromatography, Methamphetamine25
DKZEnzyme Immunoassay, Amphetamine21
NGGTest, Methamphetamine, Over The Counter18
NFTTest, Amphetamine, Over The Counter12
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter12
NGLTest, Opiates, Over The Counter12

GMDN & GCC registration

  • GMDN code 55489 · non‑implantable
  • Single‑use 100% · sterile 6% · Rx‑only 46% · OTC 48%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

No closely related category with 50+ devices.

How many amphetamine/methamphetamine group ivd, kit, rapid ict, clinical products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical", from 15 companies. The largest labeler is Ucp Biosciences, Inc. with 29% of records.

Which FDA product codes apply?

DJC (Thin Layer Chromatography, Methamphetamine), DKZ (Enzyme Immunoassay, Amphetamine), NGG (Test, Methamphetamine, Over The Counter), NFT (Test, Amphetamine, Over The Counter)

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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