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Device Explorer · FDA GUDID · GMDN 62181

Multiple clinical chemistry analyser IVD, point-of-care

A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology

US‑registered devices72in commercial distribution
Companies5labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Abbott Point Of Care Inc.5475%
Polymer Technology Systems, Inc.912%
Abbott Diagnostics Technologies As57%
Baebies, Inc.23%
Henry Schein, Inc.23%

Top labelers

CompanyDevicesShare
Abbott Point Of Care Inc.5475%
Polymer Technology Systems, Inc.912%
Abbott Diagnostics Technologies As57%
Baebies, Inc.23%
Henry Schein, Inc.23%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Afinion™ 2Alere Afinion™ AS100FINDER Cleaning AccessoryFINDERCardioChek Plus Home Self-Test AnalyzerCardioChek® Plus Professional Analyzer, RefurbisCardioChek® Plus Professional AnalyzerCardioChek® Analyzer; RefurbishedCardioChek® PA Professional Analyzer, RefurbisheCardioChek® AnalyzerCardioChek® PA analyzerCardioCheki-STATHenry Schein

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, GLUCOSE48
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL10
LBRLDL & VLDL PRECIPITATION, HDL10
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES10
CGAGlucose Oxidase, Glucose10
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER8

GMDN & GCC registration

  • GMDN code 62181 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 15% · OTC 14%
  • 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 analyser ivd, point-of-care products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple clinical chemistry analyser IVD, point-of-care", from 5 companies. The largest labeler is Abbott Point Of Care Inc. with 75% of records.

Which FDA product codes apply?

CGA (GLUCOSE OXIDASE, GLUCOSE), CHH (ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL), LBR (LDL & VLDL PRECIPITATION, HDL), JGY (COLORIMETRIC METHOD, TRIGLYCERIDES)

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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