Consulting Wallah › Device Explorer › IVD & laboratory › Plasma protein IVD, control
Device Explorer · FDA GUDID · GMDN 30506

Plasma protein IVD, control

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.

US‑registered devices88in commercial distribution
Companies10labelers on GUDID
Single‑use42%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Phadia Ab4652%
Siemens Healthcare Diagnostics Products Gmbh1517%
Abbott Laboratories1214%
Diamedix Corporation45%
Roche Diagnostics Gmbh33%
Kamiya Biomedical Company, Llc33%
Kent Laboratories Inc22%
Abbott Ireland11%

Top labelers

CompanyDevicesShare
Phadia Ab4652%
Siemens Healthcare Diagnostics Products Gmbh1517%
Abbott Laboratories1214%
Diamedix Corporation45%
Roche Diagnostics Gmbh33%
Kamiya Biomedical Company, Llc33%
Kent Laboratories Inc22%
Abbott Ireland11%
Instrumentation Laboratory Company11%
Sentinel Ch. Spa11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EliA dsDNA Positive Control 2500/5000EliA dsDNA Positive Control 250EliA ANA 3 Positive Control 2500/5000EliA ANA 3 Positive Control 250EliA CoV Positive Control C1 250Quality Club EliA AutoimmunityEliA M2 Positive Control 250EliA M2 Positive Control 100EliA CCP Positive Control 2500/5000EliA RF Positive Control 250EliA RF Positive Control 100EliA APS Positive Control 250EliA APS Positive Control 100EliA Celiac Positive Control 250ImmunoCAP Specific IgE Control HImmunoCAP Specific IgE Control M

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

FDA product codes

CodeNameDevices
JJYMulti-analyte controls, all kinds (assayed)46
JJYMulti-Analyte Controls, All Kinds (Assayed)9
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)5
JJXSingle (specified) analyte controls (assayed and unassayed)5
OHQMulti-analyte controls unassayed4
DHBSystem, test, radioallergosorbent (rast) immunological4

GMDN & GCC registration

  • GMDN code 30506 · non‑implantable
  • Single‑use 42% · sterile 0% · Rx‑only 76% · 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) · 1

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

How many plasma protein ivd, control products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Plasma protein IVD, control", from 10 companies. The largest labeler is Phadia Ab with 52% of records.

Which FDA product codes apply?

JJY (Multi-analyte controls, all kinds (assayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), 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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