Consulting Wallah › Device Explorer › IVD & laboratory › Creatinine IVD, kit, spectrophotometry
Device Explorer · FDA GUDID · GMDN 53251

Creatinine IVD, kit, spectrophotometry

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

US‑registered devices61in commercial distribution
Companies17labelers on GUDID
Single‑use31%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Roche Diagnostics Gmbh1321%
Siemens Healthcare Diagnostics Inc.1118%
Horiba Instruments Incorporated58%
Abbott Gmbh47%
Abbott Laboratories47%
Beckman Coulter, Inc.47%
Medicon Hellas S.A.35%
Sekisui Diagnostics, Llc35%

Top labelers

CompanyDevicesShare
Roche Diagnostics Gmbh1321%
Siemens Healthcare Diagnostics Inc.1118%
Horiba Instruments Incorporated58%
Abbott Gmbh47%
Abbott Laboratories47%
Beckman Coulter, Inc.47%
Medicon Hellas S.A.35%
Sekisui Diagnostics, Llc35%
Vitalscientific23%
Horiba Abx Sas23%
Carolina Liquid Chemistries Corporation23%
Diazyme Laboratories, Inc.23%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Creatinine plus ver.2Creatinine Jaffe Gen.2CreatinineCREATININE (CREA)Creatinine Jaff Gen2Creatinine plus ver2Creatinine Jaff Gen2 compensated)Creatinine Jaff methodCREATININE PAP SLENVOY 500 CREATININE REAG KITYumizen C1200 Creatinine JafféABX PENTRA CREATININE 120 CPDimension Vista® Flex® reagent cartridge ECREADimension® Flex® reagent cartridge EZCRCAROLINA LIQUID CHEMISTRIES CORP.® CREATININE RCarolina Liquid Chemistries Corp. Basic Multi-Dr

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

FDA product codes

CodeNameDevices
CGXALKALINE PICRATE, COLORIMETRY, CREATININE26
JFYENZYMATIC METHOD, CREATININE19
CGXAlkaline Picrate, Colorimetry, Creatinine14
JJXSingle (specified) analyte controls (assayed and unassayed)1
JFYEnzymatic Method, Creatinine1

GMDN & GCC registration

  • GMDN code 53251 · non‑implantable
  • Single‑use 31% · sterile 0% · Rx‑only 70% · 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) · 4

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

No closely related category with 50+ devices.

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

61 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Creatinine IVD, kit, spectrophotometry", from 17 companies. The largest labeler is Roche Diagnostics Gmbh with 21% of records.

Which FDA product codes apply?

CGX (ALKALINE PICRATE, COLORIMETRY, CREATININE), JFY (ENZYMATIC METHOD, CREATININE), CGX (Alkaline Picrate, Colorimetry, Creatinine), JJX (Single (specified) analyte 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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