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Device Explorer · FDA GUDID · GMDN 55460

Multiple 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 one or multiple drugs of abuse in a clinical specimen.

US‑registered devices146in commercial distribution
Companies9labelers on GUDID
Single‑use32%of device records
Sterile0%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Microgenics Corporation3323%
Lin-Zhi International, Inc.3021%
Abbott Laboratories2416%
Horiba Instruments Incorporated2316%
Siemens Healthcare Diagnostics Inc.2215%
Roche Diagnostics Gmbh85%
Beckman Coulter, Inc.32%
Randox Laboratories Limited21%

Top labelers

CompanyDevicesShare
Microgenics Corporation3323%
Lin-Zhi International, Inc.3021%
Abbott Laboratories2416%
Horiba Instruments Incorporated2316%
Siemens Healthcare Diagnostics Inc.2215%
Roche Diagnostics Gmbh85%
Beckman Coulter, Inc.32%
Randox Laboratories Limited21%
Instant Technologies, 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)

DOA CALCfas DAT Qualitative Plus ClinicalPreciset TDM IIPreciset TDM ICfas DAT Qualitiative PlusPreciset DAT Plus IIPreciset DAT Plus IPrecipath FructosaminePrecinormPrecipath FructosamineDRI Multi-Drug Urine Calibrator 3CEDIA Multi-Drug Calibrator Primary CutoffsDRI Multi-Drug Urine Calibrator 4CEDIA Negative CalibratorDRI Multi-Drug Urine Calibrator 1CEDIA Multi-Drug OFT Negative CalibratorCEDIA Multi-Drug OFT Cutoff Calibrator

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

FDA product codes

CodeNameDevices
DKBCalibrators, Drug Mixture73
DKBCALIBRATORS, DRUG MIXTURE28
DLJCalibrators, Drug Specific18
DIFDRUG MIXTURE CONTROL MATERIALS11
DKBCalibrators, drug mixture9
DLJCALIBRATORS, DRUG SPECIFIC8

GMDN & GCC registration

  • GMDN code 55460 · non‑implantable
  • Single‑use 32% · sterile 0% · Rx‑only 62% · 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 multiple drugs of abuse ivd, calibrator products are registered in the US?

146 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, calibrator", from 9 companies. The largest labeler is Microgenics Corporation with 23% of records.

Which FDA product codes apply?

DKB (Calibrators, Drug Mixture), DKB (CALIBRATORS, DRUG MIXTURE), DLJ (Calibrators, Drug Specific), DIF (DRUG MIXTURE CONTROL MATERIALS)

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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