Consulting Wallah › Device Explorer › IVD & laboratory › Triglyceride IVD, reagent
Device Explorer · FDA GUDID · GMDN 53462

Triglyceride 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 triglycerides in a clinical specimen.

US‑registered devices65in commercial distribution
Companies13labelers on GUDID
Single‑use40%of device records
Sterile0%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Biobase Biodustry(Shandong)Co., Ltd.2437%
Horiba Instruments Incorporated1320%
Drew Scientific, Inc.914%
Teco Diagnostics69%
Medicon Hellas S.A.23%
Alfa Wassermann, Inc.23%
Abbott Gmbh23%
Ortho-Clinical Diagnostics, Inc.23%

Top labelers

CompanyDevicesShare
Biobase Biodustry(Shandong)Co., Ltd.2437%
Horiba Instruments Incorporated1320%
Drew Scientific, Inc.914%
Teco Diagnostics69%
Medicon Hellas S.A.23%
Alfa Wassermann, Inc.23%
Abbott Gmbh23%
Ortho-Clinical Diagnostics, Inc.23%
Sterling Diagnostics Inc12%
Clearchem Diagnostics Inc.12%
Idg/Sanzay Corporation12%
Polymer Technology Systems, Inc.12%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIOBASETRIGLYCERIDESACETRIGLYCERIDES - GPOClearChem Diagnostics Inc. TriglyceridesIDG/SanzayJAS DiagnosticsPointe Triglyceride ReagentPointe Triglycerides ReagentPointe Scientific, Inc. TriglyceridePointe Scientific, Inc. TriglyceridesPointe Scientific, Inc.TriglyceridePoint ScientificPTS Panels® Triglycerides Test StripsARCHITECT

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

FDA product codes

CodeNameDevices
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides53
CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES7
JGYColorimetric Method, Triglycerides4
JIXCalibrator, Multi-Analyte Mixture1
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES1
NGOTEST, TRIGLYCERIDES, OVER THE COUNTER1

GMDN & GCC registration

  • GMDN code 53462 · non‑implantable
  • Single‑use 40% · sterile 0% · Rx‑only 38% · 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 triglyceride ivd, reagent products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Triglyceride IVD, reagent", from 13 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 37% of records.

Which FDA product codes apply?

CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), CDT (LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES), JGY (Colorimetric Method, Triglycerides), JIX (Calibrator, Multi-Analyte Mixture)

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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