Consulting Wallah › Device Explorer › IVD & laboratory › Cannabinoid/cannabinoid metabolite IVD, kit, rapid
Device Explorer · FDA GUDID · GMDN 30519

Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen within a short period, relativ

US‑registered devices140in commercial distribution
Companies35labelers on GUDID
Single‑use99%of device records
Sterile1%labelled sterile
Prescription36%Rx‑only share
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Share of device records

Safecare Biotech (Hangzhou) Co., Ltd.2216%
Easy Healthcare Corporation1813%
Germaine Laboratories, Inc118%
Hangzhou Alltest Biotech Co., Ltd.107%
Mercedes Medical, Llc107%
Medical Distribution Group Inc86%
Co-Innovation Biotech Co., Ltd64%
Alfa Scientific Designs, Inc.64%

Top labelers

CompanyDevicesShare
Safecare Biotech (Hangzhou) Co., Ltd.2216%
Easy Healthcare Corporation1813%
Germaine Laboratories, Inc118%
Hangzhou Alltest Biotech Co., Ltd.107%
Mercedes Medical, Llc107%
Medical Distribution Group Inc86%
Co-Innovation Biotech Co., Ltd64%
Alfa Scientific Designs, Inc.64%
Guangzhou Decheng Biotechnology Co., Ltd54%
Shenzhen Bioeasy Biotechnology Co., Ltd43%
Assure Tech. (Hangzhou) Co., Ltd.43%
Ucp Biosciences, Inc.43%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

U-Catch Marijuana Multi-Level Drug Test Card(ColAnalysis Oasis Marijuana (THC) Urine Strip TestDeteta THC Urine TestWelcheck Marijuana(THC) Urine Test DipcardT Testahead Marijuana(THC) Urine Test DipcardEXPLORO Highly Sensitive THC TestFIRSTVIEW Urine Test Marijuana DipCardTHC Urine Strip TestU-CatchLyherCIBIO Testco-innovationCo-innovationDOA Urine Cup 004Marijuana Panel DipMarijuana Strip

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

FDA product codes

CodeNameDevices
LDJEnzyme Immunoassay, Cannabinoids102
NFWTest, Cannabinoid, Over The Counter39
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites37
DKZEnzyme Immunoassay, Amphetamine30
DJGEnzyme Immunoassay, Opiates26
DNKThin Layer Chromatography, Morphine25

GMDN & GCC registration

  • GMDN code 30519 · non‑implantable
  • Single‑use 99% · sterile 1% · Rx‑only 36% · OTC 61%
  • 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) · 1

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

How many cannabinoid/cannabinoid metabolite ivd, kit, rapid ict, clinical products are registered in the US?

140 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical", from 35 companies. The largest labeler is Safecare Biotech (Hangzhou) Co., Ltd. with 16% of records.

Which FDA product codes apply?

LDJ (Enzyme Immunoassay, Cannabinoids), NFW (Test, Cannabinoid, Over The Counter), DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites), 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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