Consulting Wallah › Device Explorer › IVD & laboratory › Calcium (Ca2+) IVD, kit, spectrophotometry
Device Explorer · FDA GUDID · GMDN 45789

Calcium (Ca2+) IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.

US‑registered devices59in commercial distribution
Companies14labelers on GUDID
Single‑use29%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Horiba Instruments Incorporated1119%
Siemens Healthcare Diagnostics Inc.915%
Roche Diagnostics Gmbh712%
Carolina Liquid Chemistries Corporation610%
Vitalscientific58%
Beckman Coulter, Inc.58%
Abbott Gmbh47%
Stanbio Laboratory, L.P.35%

Top labelers

CompanyDevicesShare
Horiba Instruments Incorporated1119%
Siemens Healthcare Diagnostics Inc.915%
Roche Diagnostics Gmbh712%
Carolina Liquid Chemistries Corporation610%
Vitalscientific58%
Beckman Coulter, Inc.58%
Abbott Gmbh47%
Stanbio Laboratory, L.P.35%
Medicon Hellas S.A.23%
Horiba Abx Sas23%
Abbott Laboratories23%
Randox Laboratories Limited12%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Calcium Gen.2CalciumCALCIUM (Ca)Calcium Gen2CALCIUM ARSENAZOENVOY 500 SERUM CALIBRATOR KITENVOY 500 CALCIUM REAGENT KITYumizen C1200 Calcium ASABX PENTRA CALCIUM AS CPDimension Vista® Flex® reagent cartridge CADimension® Flex® reagent cartridge CACAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRCAROLINA LIQUID CHEMISTRIES CORP.™ CALCIUM REAGECAROLINA LIQUID CHEMISTRIES CORP.™ CA CALCIUM RECAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT CAROLINA LIQUID CHEMISTRIES CORP.® CA RGT. KIT

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

FDA product codes

CodeNameDevices
CJYAZO DYE, CALCIUM22
CICCresolphthalein Complexone, Calcium15
CICCRESOLPHTHALEIN COMPLEXONE, CALCIUM10
CJYAzo Dye, Calcium9
CHWTITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM5
CHWTitrimetric with EDTA and indicator, calcium2

GMDN & GCC registration

  • GMDN code 45789 · non‑implantable
  • Single‑use 29% · sterile 0% · Rx‑only 76% · 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

Total Volume (Milliliter) · 6

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

No closely related category with 50+ devices.

How many calcium (ca2+) ivd, kit, spectrophotometry products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Calcium (Ca2+) IVD, kit, spectrophotometry", from 14 companies. The largest labeler is Horiba Instruments Incorporated with 19% of records.

Which FDA product codes apply?

CJY (AZO DYE, CALCIUM), CIC (Cresolphthalein Complexone, Calcium), CIC (CRESOLPHTHALEIN COMPLEXONE, CALCIUM), CJY (Azo Dye, Calcium)

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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