Consulting Wallah › Device Explorer › IVD & laboratory › Glucose IVD, reagent
Device Explorer · FDA GUDID · GMDN 53307

Glucose 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 glucose in a clinical specimen.

US‑registered devices149in commercial distribution
Companies27labelers on GUDID
Single‑use64%of device records
Sterile0%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Fisher Diagnostics2315%
Roche Diagnostics Operations, Inc.1913%
Randox Laboratories Limited149%
I-Sens, Inc.117%
Azer Scientific Incorporated117%
Teco Diagnostics117%
Fisher Scientific Company L.L.C.107%
Cardinal Health 200, Llc96%

Top labelers

CompanyDevicesShare
Fisher Diagnostics2315%
Roche Diagnostics Operations, Inc.1913%
Randox Laboratories Limited149%
I-Sens, Inc.117%
Azer Scientific Incorporated117%
Teco Diagnostics117%
Fisher Scientific Company L.L.C.107%
Cardinal Health 200, Llc96%
Infrared Laboratory Systems Llc75%
Horiba Instruments Incorporated53%
Ysi Incorporated43%
Microtech Medical (Hangzhou) Co., Ltd.32%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GoChek2Gochek2Synermed®GLUC-HKGLUC-PAPFifty50TempoCareSens NCOOLCareSens N MultiCareSens N (MedPoint Diagnostics)TenoviScanACEVeraSens VoiceLivongo Test Strips - Mexico

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

FDA product codes

CodeNameDevices
CGAGlucose Oxidase, Glucose52
MRVDrink, Glucose Tolerance32
LFRGlucose Dehydrogenase, Glucose26
MRVDRINK, GLUCOSE TOLERANCE18
CFRHexokinase, Glucose14
NBWSystem, Test, Blood Glucose, Over The Counter11

GMDN & GCC registration

  • GMDN code 53307 · non‑implantable
  • Single‑use 64% · sterile 0% · Rx‑only 56% · OTC 16%
  • 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.

How many glucose ivd, reagent products are registered in the US?

149 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose IVD, reagent", from 27 companies. The largest labeler is Fisher Diagnostics with 15% of records.

Which FDA product codes apply?

CGA (Glucose Oxidase, Glucose), MRV (Drink, Glucose Tolerance), LFR (Glucose Dehydrogenase, Glucose), MRV (DRINK, GLUCOSE TOLERANCE)

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.

How do I get quotes?

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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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