Consulting Wallah › Device Explorer › IVD & laboratory › Multiple urine analyte IVD, control
Device Explorer · FDA GUDID · GMDN 30219

Multiple urine analyte IVD, control

A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes.

US‑registered devices174in commercial distribution
Companies29labelers on GUDID
Single‑use49%of device records
Sterile1%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Lgc Clinical Diagnostics, Inc.2514%
Bio-Rad Laboratories, Inc.1710%
Urit Medical Electronic Co., Ltd.159%
Microgenics Corporation148%
Alta Diagnostics Inc148%
Quantimetrix Corporation127%
Utak Laboratories, Inc.85%
Aalto Scientific74%

Top labelers

CompanyDevicesShare
Lgc Clinical Diagnostics, Inc.2514%
Bio-Rad Laboratories, Inc.1710%
Urit Medical Electronic Co., Ltd.159%
Microgenics Corporation148%
Alta Diagnostics Inc148%
Quantimetrix Corporation127%
Utak Laboratories, Inc.85%
Aalto Scientific74%
Randox Laboratories Limited63%
Cliniqa Corporation63%
Germaine Laboratories, Inc63%
Siemens Healthcare Diagnostics Inc.63%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

urinalysis stripsMutiple Control for SGTurbidity CalibratorSG CalibratorTurbidity ControlColor ControlSG ControlUrinalysis ControlQuality Control Solution For Urine AnalyzerCalibrator Solution For Urine AnalyzerURINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2)URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)LIQUID URINE CONTROL - LEVEL 3 (LIQ URN CONTROL LIQUID URINE CONTROL - LEVEL 2 (LIQ URN CONTROL ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROLASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL

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

FDA product codes

CodeNameDevices
JJWUrinalysis Controls (Assayed And Unassayed)86
JJYMulti-Analyte Controls, All Kinds (Assayed)35
JJWURINALYSIS CONTROLS (ASSAYED AND UNASSAYED)18
JJWUrinalysis controls (assayed and unassayed)15
LASDrug Specific Control Materials8
KQOAUTOMATED URINALYSIS SYSTEM4

GMDN & GCC registration

  • GMDN code 30219 · non‑implantable
  • Single‑use 49% · sterile 1% · Rx‑only 40% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 26Total Volume (Microliter) · 1Total Volume (Gallon) · 1

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

How many multiple urine analyte ivd, control products are registered in the US?

174 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple urine analyte IVD, control", from 29 companies. The largest labeler is Lgc Clinical Diagnostics, Inc. with 14% of records.

Which FDA product codes apply?

JJW (Urinalysis Controls (Assayed And Unassayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JJW (URINALYSIS CONTROLS (ASSAYED AND UNASSAYED)), JJW (Urinalysis controls (assayed and unassayed))

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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