Consulting Wallah › Device Explorer › IVD & laboratory › Inorganic phosphate (PO43-) IVD, reagent
Device Explorer · FDA GUDID · GMDN 52891

Inorganic phosphate (PO43-) 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 inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

US‑registered devices53in commercial distribution
Companies15labelers on GUDID
Single‑use28%of device records
Sterile0%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Biobase Biodustry(Shandong)Co., Ltd.1325%
Horiba Instruments Incorporated1223%
Infrared Laboratory Systems Llc713%
Abbott Gmbh48%
Drew Scientific, Inc.36%
Teco Diagnostics36%
Medicon Hellas S.A.24%
Abbott Laboratories24%

Top labelers

CompanyDevicesShare
Biobase Biodustry(Shandong)Co., Ltd.1325%
Horiba Instruments Incorporated1223%
Infrared Laboratory Systems Llc713%
Abbott Gmbh48%
Drew Scientific, Inc.36%
Teco Diagnostics36%
Medicon Hellas S.A.24%
Abbott Laboratories24%
Abaxis, Inc.12%
Alfa Wassermann, Inc.12%
Clearchem Diagnostics Inc.12%
Idg/Sanzay Corporation12%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIOBASEPhosphorusSynermed®Piccolo Renal Function PanelACEClearChem Diagnostics Inc. Inorganic PhosphorousIDG/SanzayJAS DiagnosticsPhosphorous ReagentPhosphorus ReagentPointe Phosphorus ReagentPointe Scientific, Inc. PhosphorusPointe Scientific, Inc.ARCHITECTAlinityVITROS

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

FDA product codes

CodeNameDevices
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus44
CEOPhosphomolybdate (colorimetric), inorganic phosphorus8
CHJMercuric Thiocyanate, Colorimetry, Chloride1
JGSElectrode, Ion Specific, Sodium1
KHSEnzymatic, Carbon-Dioxide1
CEMElectrode, Ion Specific, Potassium1

GMDN & GCC registration

  • GMDN code 52891 · non‑implantable
  • Single‑use 28% · sterile 0% · Rx‑only 58% · OTC 2%
  • 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) · 6Total Volume (Liter) · 1

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

No closely related category with 50+ devices.

How many inorganic phosphate (po43-) ivd, reagent products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inorganic phosphate (PO43-) IVD, reagent", from 15 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 25% of records.

Which FDA product codes apply?

CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), CEO (Phosphomolybdate (colorimetric), inorganic phosphorus), CHJ (Mercuric Thiocyanate, Colorimetry, Chloride), JGS (Electrode, Ion Specific, Sodium)

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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