Consulting Wallah › Device Explorer › IVD & laboratory › Immunohistochemistry antibody diluent IVD
Device Explorer · FDA GUDID · GMDN 57769

Immunohistochemistry antibody diluent IVD

A substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.

US‑registered devices79in commercial distribution
Companies12labelers on GUDID
Single‑use13%of device records
Sterile0%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Immunalysis Corp2329%
Biocare Medical Llc1722%
Bio Sb, Inc.1620%
Diagnostic Biosystems, Inc.45%
Biogenex Laboratories45%
Sakura Finetek U.S.A., Inc.45%
Immunodiagnostic Systems Limited23%
Leica Biosystems Newcastle Ltd23%

Top labelers

CompanyDevicesShare
Immunalysis Corp2329%
Biocare Medical Llc1722%
Bio Sb, Inc.1620%
Diagnostic Biosystems, Inc.45%
Biogenex Laboratories45%
Sakura Finetek U.S.A., Inc.45%
Immunodiagnostic Systems Limited23%
Leica Biosystems Newcastle Ltd23%
Ventana Medical Systems, Inc.23%
Drew Scientific, Inc.23%
Slmp, Llc23%
Diasorin Molecular Llc11%

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

Brand names on the register (sample)

IDS-iSYS Diluent BIDS-iSYS Diluent ABONDNovocastra™VENTANA Antibody Diluent with CaseinAntibody DiluentVP Monet Blue DiluentRevival Series SamplerRenaissance Background Reducing DiluentRenoir Red DiluentVan Gogh DiluentVan Gogh Yellow DiluentMonet Blue DiluentDa Vinci Green DiluentFluorescence Antibody DiluentDiagnostic BioSystems

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

FDA product codes

CodeNameDevices
PPMGeneral Purpose Reagent64
NJTImmunohistochemistry Reagents And Kits4
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 2
JCCpH buffer2
PPMGeneral purpose reagent2
GIFDiluent, Blood Cell2

GMDN & GCC registration

  • GMDN code 57769 · non‑implantable
  • Single‑use 13% · sterile 0% · Rx‑only 30% · 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

No structured size data on the register.

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How many immunohistochemistry antibody diluent ivd products are registered in the US?

79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Immunohistochemistry antibody diluent IVD", from 12 companies. The largest labeler is Immunalysis Corp with 29% of records.

Which FDA product codes apply?

PPM (General Purpose Reagent), NJT (Immunohistochemistry Reagents And Kits), LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted ), JCC (pH buffer)

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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