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Device Explorer · FDA GUDID · GMDN 64705

Assay development analyte-specific reagent IVD

An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological sp

US‑registered devices4,574in commercial distribution
Companies29labelers on GUDID
Single‑use27%of device records
Sterile0%labelled sterile
Prescription16%Rx‑only share
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Share of device records

Cytocell Limited1,88841%
Immunotech69615%
Metasystems Probes Gmbh52712%
Biolegend, Inc.3909%
Bio Sb, Inc.2886%
Cell Marque Corporation2085%
Lumatas Biosystems, Inc.1193%
Immunalysis Corp972%

Top labelers

CompanyDevicesShare
Cytocell Limited1,88841%
Immunotech69615%
Metasystems Probes Gmbh52712%
Biolegend, Inc.3909%
Bio Sb, Inc.2886%
Cell Marque Corporation2085%
Lumatas Biosystems, Inc.1193%
Immunalysis Corp972%
Miltenyi Biotec B.V. & Co. Kg882%
Fort Worth Diagnostics, Llc792%
Leica Biosystems Newcastle Ltd371%
Invivoscribe, Inc.311%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IBDX ASR PLATE SACCHAROMYCESIBDX ASR PLATE MANNOBIOSIDEIBDX ASR PLATE LAMINARIBIOSIDEIBDX ASR PLATE CHITOBIOSIDEBordetella immunology reagents IgMBordetella immunology reagents IgALysoPC ISIduronate 2-sulfatase S&ISMonoclonal Mouse Anti-Human Integrin Beta-6, CloCytoCellSolid Tumor Growth SupplementProduct of Conception Growth SupplementLymphoma Growth SupplementSkin Growth SupplementCytoclear Cytoplasm RemoverOptimal Hypotonic Solution

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

FDA product codes

CodeNameDevices
MVUReagents, Specific, Analyte4,358
MVUReagents, specific, analyte414
KIQKit, Culture, Chromosome14
DHBSystem, Test, Radioallergosorbent (Rast) Immunological1

GMDN & GCC registration

  • GMDN code 64705 · non‑implantable
  • Single‑use 27% · sterile 0% · Rx‑only 16% · 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 (Microliter) · 390Total Volume (Milliliter) · 295

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

How many assay development analyte-specific reagent ivd products are registered in the US?

4,574 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Assay development analyte-specific reagent IVD", from 29 companies. The largest labeler is Cytocell Limited with 41% of records.

Which FDA product codes apply?

MVU (Reagents, Specific, Analyte), MVU (Reagents, specific, analyte), KIQ (Kit, Culture, Chromosome), DHB (System, Test, Radioallergosorbent (Rast) Immunological)

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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