Consulting Wallah › Device Explorer › IVD & laboratory › Uric acid IVD, reagent
Device Explorer · FDA GUDID · GMDN 53586

Uric acid IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen.

US‑registered devices72in commercial distribution
Companies16labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription42%Rx‑only share
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Share of device records

Biobase Biodustry(Shandong)Co., Ltd.1825%
Horiba Instruments Incorporated1318%
Drew Scientific, Inc.1014%
Teco Diagnostics811%
Infrared Laboratory Systems Llc710%
Fora Care Inc.34%
Medicon Hellas S.A.23%
Apex Biotechnology Corp.23%

Top labelers

CompanyDevicesShare
Biobase Biodustry(Shandong)Co., Ltd.1825%
Horiba Instruments Incorporated1318%
Drew Scientific, Inc.1014%
Teco Diagnostics811%
Infrared Laboratory Systems Llc710%
Fora Care Inc.34%
Medicon Hellas S.A.23%
Apex Biotechnology Corp.23%
Alfa Wassermann, Inc.23%
Sterling Diagnostics Inc11%
Clearchem Diagnostics Inc.11%
Idg/Sanzay Corporation11%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIOBASEUric AcidSynermed®UASure II Blood Uric Acid Test Strips 25sUASure II Blood Uric Acid Monitoring SystemACEENZYMATIC URIC ACIDClearChem Diagnostics Inc. Uric AcidIDG/SanzayHeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX)JAS DiagnosticsFORAUric Acid ReagentPointe Uric Acid ReagentPointe Scientific, Inc. Uric AcidPointe Scientific, Inc.

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

FDA product codes

CodeNameDevices
KNKAcid, Uric, Uricase (Colorimetric)61
LFQAcid, Uric, Acid Reduction Of Ferric Ion4
PTCUric Acid Test System For At Home Prescription Use3
KNKAcid, uric, uricase (colorimetric)2
JIXCalibrator, Multi-Analyte Mixture1

GMDN & GCC registration

  • GMDN code 53586 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 42% · 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) · 7Total Volume (Liter) · 1

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

No closely related category with 50+ devices.

How many uric acid ivd, reagent products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uric acid IVD, reagent", from 16 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 25% of records.

Which FDA product codes apply?

KNK (Acid, Uric, Uricase (Colorimetric)), LFQ (Acid, Uric, Acid Reduction Of Ferric Ion), PTC (Uric Acid Test System For At Home Prescription Use), KNK (Acid, uric, uricase (colorimetric))

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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