Consulting Wallah › Device Explorer › IVD & laboratory › Glucose IVD, kit, electrometry
Device Explorer · FDA GUDID · GMDN 53303

Glucose IVD, kit, electrometry

A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedi

US‑registered devices227in commercial distribution
Companies54labelers on GUDID
Single‑use90%of device records
Sterile2%labelled sterile
Prescription7%Rx‑only share
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Share of device records

Hmd Biomedical Inc.4319%
Fora Care Inc.2611%
Tyson Bioresearch Inc.2310%
Able Diagnostics Inc104%
Lifescan Europe Gmbh104%
Osang Healthcare Co., Ltd.84%
Ok Biotech Co., Ltd.73%
Prodigy Diabetes Care, Llc73%

Top labelers

CompanyDevicesShare
Hmd Biomedical Inc.4319%
Fora Care Inc.2611%
Tyson Bioresearch Inc.2310%
Able Diagnostics Inc104%
Lifescan Europe Gmbh104%
Osang Healthcare Co., Ltd.84%
Ok Biotech Co., Ltd.73%
Prodigy Diabetes Care, Llc73%
Lifescan U.S. Llc63%
Pharma Tech Solutions, Inc.52%
Mio Labs Inc.52%
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.42%

Company = labeler of record on GUDID. 54 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

telli healthbiolandBioHermes Blood Glucose Control SolutionBioHermes Limpid Blood Glucose Test StripsBioHermes GluCoA1c Blood Glucose Test StripsWellueElectrode for ABL analyzersMembrane for E7066 electrodeXPER Technology Procheck Witty Procheck Smart BlWowGoHealth Blood Glucose Test Strips - GSH-BGM9NuvoMedPerfect 3OracleBG 150 Blood Glucose Test Strip(50T)medisana BG 150 Blood Glucose Test Strips (50Tx2TysonBio AC500 PRO Blood Glucose Test Strips (50

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

FDA product codes

CodeNameDevices
NBWSystem, Test, Blood Glucose, Over The Counter142
CGAGlucose Oxidase, Glucose77
LFRGlucose Dehydrogenase, Glucose61
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)29
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER13
CGAGLUCOSE OXIDASE, GLUCOSE12

GMDN & GCC registration

  • GMDN code 53303 · non‑implantable
  • Single‑use 90% · sterile 2% · Rx‑only 7% · OTC 52%
  • 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 (Microliter) · 11Needle Gauge (Gauge) · 1

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

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

227 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose IVD, kit, electrometry", from 54 companies. The largest labeler is Hmd Biomedical Inc. with 19% of records.

Which FDA product codes apply?

NBW (System, Test, Blood Glucose, Over The Counter), CGA (Glucose Oxidase, Glucose), LFR (Glucose Dehydrogenase, Glucose), JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))

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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