Consulting Wallah › Device Explorer › IVD & laboratory › Multiple biogenic amine neurotransmitter IVD, reag
Device Explorer · FDA GUDID · GMDN 63824

Multiple biogenic amine neurotransmitter IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norep

US‑registered devices81in commercial distribution
Companies3labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Chromsystems Instruments + Chemicals Gmbh7998%
Drg Instruments Gesellschaft Mit Beschränkter Haftung11%
Drg International Inc11%

Top labelers

CompanyDevicesShare
Chromsystems Instruments + Chemicals Gmbh7998%
Drg Instruments Gesellschaft Mit Beschränkter Haftung11%
Drg International Inc11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ReagentAccessorieHistamine ELISA

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

FDA product codes

CodeNameDevices
CHQChromatographic/Fluorometric Method, Catecholamines72
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Ac8
CHQCHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES6
IAFWright'S Stain2

GMDN & GCC registration

  • GMDN code 63824 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 2% · 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) · 2

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

How many multiple biogenic amine neurotransmitter ivd, reagent products are registered in the US?

81 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple biogenic amine neurotransmitter IVD, reagent", from 3 companies. The largest labeler is Chromsystems Instruments + Chemicals Gmbh with 98% of records.

Which FDA product codes apply?

CHQ (Chromatographic/Fluorometric Method, Catecholamines), CDA (Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Ac), CHQ (CHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES), IAF (Wright'S Stain)

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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