Consulting Wallah › Device Explorer › IVD & laboratory › Alanine aminotransferase (ALT) IVD, reagent
Device Explorer · FDA GUDID · GMDN 52925

Alanine aminotransferase (ALT) 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 alanine aminotransferase (ALT) in a clinical specimen.

US‑registered devices56in commercial distribution
Companies14labelers on GUDID
Single‑use39%of device records
Sterile0%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Biobase Biodustry(Shandong)Co., Ltd.1832%
Infrared Laboratory Systems Llc712%
Abbott Gmbh59%
Teco Diagnostics59%
Abbott Ireland47%
Urit Medical Electronic Co., Ltd.35%
Abbott Laboratories35%
Alfa Wassermann, Inc.24%

Top labelers

CompanyDevicesShare
Biobase Biodustry(Shandong)Co., Ltd.1832%
Infrared Laboratory Systems Llc712%
Abbott Gmbh59%
Teco Diagnostics59%
Abbott Ireland47%
Urit Medical Electronic Co., Ltd.35%
Abbott Laboratories35%
Alfa Wassermann, Inc.24%
Horiba Instruments Incorporated24%
Siemens Healthcare Diagnostics Inc.24%
Ortho-Clinical Diagnostics, Inc.24%
Sterling Diagnostics Inc12%

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

Brand names on the register (sample)

BIOBASEAlanine Aminotransferase Test StripSynermed®ACESGPT ColorimetricClearChem Diagnostics Inc. Alanine aminotransferIDG/SANZAYPointe ScientificPointe Scientfic Inc.ADVIA® Chemistry P5P Pyridoxal-5-Phosphate ReageARCHITECTAlinityVITROSTeco Diagnostics ALT (SGPT) Reagent Set (ColorimALT (SGPT) REAGENT SET (UV-KINETIC METHOD)ALT (SGPT) KINETIC METHOD TC MATRIX-240/480

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

FDA product codes

CodeNameDevices
CKANadh Oxidation/Nad Reduction, Alt/Sgpt34
CKANADH OXIDATION/NAD REDUCTION, ALT/SGPT16
CKDHydrazone Colorimetry, Alt/Sgpt4
CITNadh oxidation/nad reduction, ast/sgot2
CJOALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES1

GMDN & GCC registration

  • GMDN code 52925 · non‑implantable
  • Single‑use 39% · sterile 0% · Rx‑only 50% · OTC 2%
  • 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) · 8Total Volume (Liter) · 1

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

No closely related category with 50+ devices.

How many alanine aminotransferase (alt) ivd, reagent products are registered in the US?

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Alanine aminotransferase (ALT) IVD, reagent", from 14 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 32% of records.

Which FDA product codes apply?

CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), CKA (NADH OXIDATION/NAD REDUCTION, ALT/SGPT), CKD (Hydrazone Colorimetry, Alt/Sgpt), CIT (Nadh oxidation/nad reduction, ast/sgot)

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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