Consulting Wallah › Device Explorer › IVD & laboratory › Cannabinoid/cannabinoid metabolite IVD, calibrator
Device Explorer · FDA GUDID · GMDN 55551

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

US‑registered devices69in commercial distribution
Companies9labelers on GUDID
Single‑use41%of device records
Sterile0%labelled sterile
Prescription61%Rx‑only share
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Share of device records

Immunalysis Corp1623%
Microgenics Corporation1522%
Lin-Zhi International, Inc.1217%
Horiba Instruments Incorporated913%
Abbott Laboratories710%
Ark Diagnostics Inc46%
Beckman Coulter, Inc.46%
Randox Laboratories Limited11%

Top labelers

CompanyDevicesShare
Immunalysis Corp1623%
Microgenics Corporation1522%
Lin-Zhi International, Inc.1217%
Horiba Instruments Incorporated913%
Abbott Laboratories710%
Ark Diagnostics Inc46%
Beckman Coulter, Inc.46%
Randox Laboratories Limited11%
Ortho-Clinical Diagnostics, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

THC CALDRI THC 20 ng/mL Urine CalibratorDRI THC 100 ng/mL Urine CalibratorDRI THC 50 ng/mL Urine CalibratorDRI THC 200 ng/mL Urine CalibratorCEDIA THC OFT Negative CalibratorCEDIA THC OFT Cutoff CalibratorCEDIA THC 150 CalibratorCEDIA THC 100 CalibratorCEDIA THC 75 CalibratorCEDIA THC 50 CalibratorCEDIA THC 25 CalibratorImmunalysisImmunalysis CorporationARK™ AB-PINACA Cutoff CalibratorARK™ AB-PINACA Negative Calibrator

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

FDA product codes

CodeNameDevices
DLJCalibrators, Drug Specific47
DLJCalibrators, drug specific11
DLJCALIBRATORS, DRUG SPECIFIC5
JITCalibrator, Secondary1
LDJENZYME IMMUNOASSAY, CANNABINOIDS1
DKBCalibrators, Drug Mixture1

GMDN & GCC registration

  • GMDN code 55551 · non‑implantable
  • Single‑use 41% · sterile 0% · Rx‑only 61% · OTC 0%
  • 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.

How many cannabinoid/cannabinoid metabolite ivd, calibrator products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cannabinoid/cannabinoid metabolite IVD, calibrator", from 9 companies. The largest labeler is Immunalysis Corp with 23% of records.

Which FDA product codes apply?

DLJ (Calibrators, Drug Specific), DLJ (Calibrators, drug specific), DLJ (CALIBRATORS, DRUG SPECIFIC), JIT (Calibrator, Secondary)

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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