Consulting Wallah › Device Explorer › IVD & laboratory › Glucose IVD, kit, spectrophotometry
Device Explorer · FDA GUDID · GMDN 53301

Glucose IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry method.

US‑registered devices84in commercial distribution
Companies16labelers on GUDID
Single‑use25%of device records
Sterile0%labelled sterile
Prescription61%Rx‑only share
ShareLinkedIn

Share of device records

Roche Diagnostics Operations, Inc.1417%
Horiba Instruments Incorporated1113%
Roche Diagnostics Gmbh911%
Siemens Healthcare Diagnostics Inc.911%
Carolina Liquid Chemistries Corporation67%
Stanbio Laboratory, L.P.56%
Vitalscientific45%
Horiba Abx Sas45%

Top labelers

CompanyDevicesShare
Roche Diagnostics Operations, Inc.1417%
Horiba Instruments Incorporated1113%
Roche Diagnostics Gmbh911%
Siemens Healthcare Diagnostics Inc.911%
Carolina Liquid Chemistries Corporation67%
Stanbio Laboratory, L.P.56%
Vitalscientific45%
Horiba Abx Sas45%
Abbott Gmbh45%
Abbott Ireland45%
Beckman Coulter, Inc.45%
Wal-Mart Stores, Inc.34%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Glucose HK Gen. 3Glucose HKGlucoseGlucoquant GlucoseHKGlucose HK Gen3GLUCOSE PAP SLENVOY 500 GLUCOSE REAGENT KITYumizen C1200 Glucose HKABX PENTRA GLUCOSE PAP CPABX PENTRA GLUCOSE HK CPDimension Vista® Flex® reagent cartridge GLUDimension® Flex® reagent cartridge GLUCCAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PCAROLINA LIQUID CHEMISTRIES CORP.® GLUCOSE REAGECAROLINA LIQUID CHEMISTRIES CORP.® GLU GLUCOSE RCAROLINA LIQUID CHEMISTRIES CORP.® GLU RGT. KIT

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

FDA product codes

CodeNameDevices
CFRHEXOKINASE, GLUCOSE34
NBWSystem, Test, Blood Glucose, Over The Counter32
CFRHexokinase, Glucose16
CGAGlucose Oxidase, Glucose8
CGAGLUCOSE OXIDASE, GLUCOSE6
OZPAutomated Insulin Dosing Device System, Single Hormonal Cont6

GMDN & GCC registration

  • GMDN code 53301 · non‑implantable
  • Single‑use 25% · sterile 0% · Rx‑only 61% · OTC 1%
  • 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) · 7

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

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

84 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glucose IVD, kit, spectrophotometry", from 16 companies. The largest labeler is Roche Diagnostics Operations, Inc. with 17% of records.

Which FDA product codes apply?

CFR (HEXOKINASE, GLUCOSE), NBW (System, Test, Blood Glucose, Over The Counter), CFR (Hexokinase, Glucose), CGA (Glucose Oxidase, Glucose)

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?

Add glucose ivd, kit, spectrophotometry to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Glucose IVD, kit, spectrophotometry

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying glucose ivd, kit, spectrophotometry for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →