Consulting Wallah › Device Explorer › IVD & laboratory › Gamma-glutamyltransferase (GGT) IVD, reagent
Device Explorer · FDA GUDID · GMDN 53030

Gamma-glutamyltransferase (GGT) 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 gamma glutamyltransferase (GGT) in a clinical specimen.

US‑registered devices51in commercial distribution
Companies12labelers on GUDID
Single‑use41%of device records
Sterile0%labelled sterile
Prescription55%Rx‑only share
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Share of device records

Biobase Biodustry(Shandong)Co., Ltd.1835%
Horiba Instruments Incorporated714%
Infrared Laboratory Systems Llc612%
Teco Diagnostics612%
Abbott Ireland48%
Abbott Gmbh36%
Abaxis, Inc.24%
Alfa Wassermann, Inc.12%

Top labelers

CompanyDevicesShare
Biobase Biodustry(Shandong)Co., Ltd.1835%
Horiba Instruments Incorporated714%
Infrared Laboratory Systems Llc612%
Teco Diagnostics612%
Abbott Ireland48%
Abbott Gmbh36%
Abaxis, Inc.24%
Alfa Wassermann, Inc.12%
Clearchem Diagnostics Inc.12%
Clinical Diagnostic Solutions, Inc.12%
Abbott Laboratories12%
Ortho-Clinical Diagnostics, Inc.12%

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

Brand names on the register (sample)

BIOBASESynermed®Piccolo General Chemistry 6Piccolo Liver Panel PlusACEClearChem Diagnostics Inc. Gamma-glutamyltransfeGGT Reagent SetPointe GGT ReagentPointe Scientific, Inc.Pointe Scientific, Inc. GGT R1Pointe Scientific Inc. GGTARCHITECTAlinityVITROSTeco Diagnostics TC-Matrix Gamma-GT Reagent KitTeco Diagnostics g-Glutamyl Transferase (GGT) Li

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

FDA product codes

CodeNameDevices
JQBKinetic Method, Gamma-Glutamyl Transpeptidase20
JPZColorimetric Method, Gamma-Glutamyl Transpeptidase19
JPZCOLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE9
CKANadh Oxidation/Nad Reduction, Alt/Sgpt2
CITNadh Oxidation/Nad Reduction, Ast/Sgot2
JQBKINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE2

GMDN & GCC registration

  • GMDN code 53030 · non‑implantable
  • Single‑use 41% · sterile 0% · Rx‑only 55% · 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) · 1

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

No closely related category with 50+ devices.

How many gamma-glutamyltransferase (ggt) ivd, reagent products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gamma-glutamyltransferase (GGT) IVD, reagent", from 12 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 35% of records.

Which FDA product codes apply?

JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), JPZ (COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE), CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)

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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