Consulting Wallah › Device Explorer › IVD & laboratory › Urea IVD, kit, enzyme spectrophotometry
Device Explorer · FDA GUDID · GMDN 53587

Urea IVD, kit, enzyme spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. I

US‑registered devices51in commercial distribution
Companies13labelers on GUDID
Single‑use51%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Horiba Instruments Incorporated1325%
Beckman Coulter, Inc.918%
Roche Diagnostics Gmbh714%
Siemens Healthcare Diagnostics Inc.510%
Stanbio Laboratory, L.P.48%
Horiba Abx Sas36%
Medtest Dx, Inc.36%
Vitalscientific24%

Top labelers

CompanyDevicesShare
Horiba Instruments Incorporated1325%
Beckman Coulter, Inc.918%
Roche Diagnostics Gmbh714%
Siemens Healthcare Diagnostics Inc.510%
Stanbio Laboratory, L.P.48%
Horiba Abx Sas36%
Medtest Dx, Inc.36%
Vitalscientific24%
Randox Laboratories Limited12%
Fisher Diagnostics12%
Clinical Diagnostic Solutions, Inc.12%
Diamond Diagnostics Inc.12%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Urea/BunUREAKinetic UV assay for ureaurea nitrogenUreaBUNUREABUNUREA UV SLENVOY 500 BUN REAGENT KITYumizen C1200 Uric acidYumizen C1200 UreaABX PENTRA UREA CPThermo Scientific Infinity™Dimension Vista® Flex® reagent cartridge BUNDimension® Flex® reagent cartridge BUNBUN/BS200BUN/Polychem 180BUN/BS480

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

FDA product codes

CodeNameDevices
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen32
CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN12
KNKAcid, Uric, Uricase (Colorimetric)1
JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US1
CDLBerthelot Indophenol, Urea Nitrogen1
CDWDiacetyl-Monoxime, Urea Nitrogen1

GMDN & GCC registration

  • GMDN code 53587 · non‑implantable
  • Single‑use 51% · sterile 0% · Rx‑only 80% · 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.

No closely related category with 50+ devices.

How many urea ivd, kit, enzyme spectrophotometry products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urea IVD, kit, enzyme spectrophotometry", from 13 companies. The largest labeler is Horiba Instruments Incorporated with 25% of records.

Which FDA product codes apply?

CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), CDQ (UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN), KNK (Acid, Uric, Uricase (Colorimetric)), JJE (ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL US)

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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