Consulting Wallah › Device Explorer › IVD & laboratory › Total cholesterol lipid IVD, kit, spectrophotometr
Device Explorer · FDA GUDID · GMDN 53359

Total cholesterol lipid IVD, kit, spectrophotometry

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

US‑registered devices64in commercial distribution
Companies17labelers on GUDID
Single‑use39%of device records
Sterile0%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Horiba Instruments Incorporated1219%
Sd Biosensor, Inc.69%
Carolina Liquid Chemistries Corporation58%
Acon Laboratories, Inc.58%
Beckman Coulter, Inc.58%
Roche Diagnostics Gmbh46%
Randox Laboratories Limited46%
Vitalscientific46%

Top labelers

CompanyDevicesShare
Horiba Instruments Incorporated1219%
Sd Biosensor, Inc.69%
Carolina Liquid Chemistries Corporation58%
Acon Laboratories, Inc.58%
Beckman Coulter, Inc.58%
Roche Diagnostics Gmbh46%
Randox Laboratories Limited46%
Vitalscientific46%
Siemens Healthcare Diagnostics Inc.46%
Stanbio Laboratory, L.P.35%
Abbott Ireland35%
Medicon Hellas S.A.23%

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

Brand names on the register (sample)

CholesterolCHOLESTEROL (CHOL)CHOLCholesterol Gen.2CHOLESTEROL SLENVOY 500 CHOLESTEROL REAGENT KITYumizen C1200 CholesterolABX PENTRA CHOLESTEROL CPSTANDARD™ LipidoCare Lipid Test Strip - Lipid PrSTANDARD™ LipidoCare AnalyzerIDG/SanzayDimension Vista® Flex® reagent cartridge CHOLDimension® Flex® reagent cartridge CHOLCAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL RCAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL RCAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL R

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

FDA product codes

CodeNameDevices
CHHEnzymatic Esterase--Oxidase, Cholesterol33
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL25
JGYColorimetric Method, Triglycerides6
LBRLdl & Vldl Precipitation, Hdl6
LBRLDL & VLDL PRECIPITATION, HDL5
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES5

GMDN & GCC registration

  • GMDN code 53359 · non‑implantable
  • Single‑use 39% · sterile 0% · Rx‑only 67% · OTC 19%
  • 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) · 10Total Volume (Liter) · 1

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

How many total cholesterol lipid ivd, kit, spectrophotometry products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total cholesterol lipid IVD, kit, spectrophotometry", from 17 companies. The largest labeler is Horiba Instruments Incorporated with 19% of records.

Which FDA product codes apply?

CHH (Enzymatic Esterase--Oxidase, Cholesterol), CHH (ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL), JGY (Colorimetric Method, Triglycerides), LBR (Ldl & Vldl Precipitation, Hdl)

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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