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Device Explorer · FDA GUDID · GMDN 62643

Multiple clinical chemistry analyte monitoring system IVD, home-use

A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used toge

US‑registered devices115in commercial distribution
Companies17labelers on GUDID
Single‑use67%of device records
Sterile1%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Abbott Diabetes Care Inc4337%
Fora Care Inc.1917%
Stanbio Laboratory, L.P.98%
Gojji, Inc.76%
Acon Laboratories, Inc.76%
Ketobm Usa Llc54%
E-Linkcare Meditech Co., Ltd43%
Wal-Mart Stores, Inc.43%

Top labelers

CompanyDevicesShare
Abbott Diabetes Care Inc4337%
Fora Care Inc.1917%
Stanbio Laboratory, L.P.98%
Gojji, Inc.76%
Acon Laboratories, Inc.76%
Ketobm Usa Llc54%
E-Linkcare Meditech Co., Ltd43%
Wal-Mart Stores, Inc.43%
Nova Biomedical Corporation43%
Taidoc Technology Corporation22%
I-Sens, Inc.22%
Bruno Pharma Innovations, Llc22%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Blood Ketone Control solution(level 3)Blood Ketone Control solution(level 2)Blood Ketone Control solution(level 1)Blood Ketone Monitoring SystemBlood Lipid Test StripXPER Technology Multi-Functional Monitoring SystXPER Technology Multi-Functional Monitoring SystKetoSensBrunoKetoBMbkt ß-Ketone & blood glucose monitoring systemketo mojo β-ketone & blood glucose monitoring sGOJJI KETONE CONTROL SOLUTION-L1GOJJI BLOOD KETONE TEST STRIPGOJJI Plus TestNGo MULTIFUNCTION (GLUC-KETONE) MGOJJI MULTIFUNCTION (GLUC-KETONE) METER

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 COUNTER57
LFRGlucose dehydrogenase, glucose50
NBWSystem, Test, Blood Glucose, Over The Counter31
JINNitroprusside, Ketones (Urinary, Non-Quant.)23
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)16
JJXSingle (specified) analyte controls (assayed and unassayed)9

GMDN & GCC registration

  • GMDN code 62643 · non‑implantable
  • Single‑use 67% · sterile 1% · Rx‑only 8% · OTC 63%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many multiple clinical chemistry analyte monitoring system ivd, home-use products are registered in the US?

115 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple clinical chemistry analyte monitoring system IVD, home-use", from 17 companies. The largest labeler is Abbott Diabetes Care Inc with 37% of records.

Which FDA product codes apply?

NBW (SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER), LFR (Glucose dehydrogenase, glucose), NBW (System, Test, Blood Glucose, Over The Counter), JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))

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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