Consulting Wallah › Device Explorer › IVD & laboratory › Glycated haemoglobin (HbA1c) IVD, control
Device Explorer · FDA GUDID · GMDN 44435

Glycated haemoglobin (HbA1c) IVD, control

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

US‑registered devices89in commercial distribution
Companies27labelers on GUDID
Single‑use49%of device records
Sterile0%labelled sterile
Prescription45%Rx‑only share
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Share of device records

Bio-Rad Laboratories, Inc.2326%
Horiba Instruments Incorporated89%
Microgenics Corporation56%
Abbott Diagnostics Technologies As44%
Randox Laboratories Limited44%
Vitalscientific44%
Diazyme Laboratories, Inc.44%
Aalto Scientific44%

Top labelers

CompanyDevicesShare
Bio-Rad Laboratories, Inc.2326%
Horiba Instruments Incorporated89%
Microgenics Corporation56%
Abbott Diagnostics Technologies As44%
Randox Laboratories Limited44%
Vitalscientific44%
Diazyme Laboratories, Inc.44%
Aalto Scientific44%
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.33%
Primus Corporation33%
Lgc Clinical Diagnostics, Inc.33%
Streck, Inc.33%

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

Brand names on the register (sample)

Afinion HbA1c Calibration VerificationAfinion HbA1c ControlAlere Afinion HbA1c ControlBioHermes Glycohemoglobin Quality Control (HPLC)BioHermes Glycohemoglobin Quality ControlTrinity BiotechLiquid Glycated Haemoglobin (HbA1c) Control LeveLiquid Glycated Haemoglobin (HbA1c) Control LeveLiquid Glycated Haemoglobin (HbA1c) Control set HbA1C CONTROLHemoglobin A1c Control SetPreciControl HbA1c pathPreciControl HbA1c normDirect A1c Control KitHbA1c CONTROL L+ HLiquichek

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

FDA product codes

CodeNameDevices
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)28
JJXSingle (specified) analyte controls (assayed and unassayed)13
LCPAssay, Glycosylated Hemoglobin11
GGMControl, hemoglobin8
GGMCONTROL, HEMOGLOBIN8
LCPASSAY, GLYCOSYLATED HEMOGLOBIN4

GMDN & GCC registration

  • GMDN code 44435 · non‑implantable
  • Single‑use 49% · sterile 0% · Rx‑only 45% · OTC 0%
  • 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) · 4

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How many glycated haemoglobin (hba1c) ivd, control products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glycated haemoglobin (HbA1c) IVD, control", from 27 companies. The largest labeler is Bio-Rad Laboratories, Inc. with 26% of records.

Which FDA product codes apply?

JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), JJX (Single (specified) analyte controls (assayed and unassayed)), LCP (Assay, Glycosylated Hemoglobin), GGM (Control, hemoglobin)

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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