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Device Explorer · FDA GUDID · GMDN 43587

Biological stain IVD

A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, ident

US‑registered devices620in commercial distribution
Companies35labelers on GUDID
Single‑use48%of device records
Sterile0%labelled sterile
Prescription13%Rx‑only share
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Share of device records

Richard-Allan Scientific Company16126%
Remel, Inc.7612%
Calibrescientific Us, Inc.528%
Transene Company, Inc.498%
Scientific Device Laboratory, Inc.366%
Leica Biosystems Richmond, Inc.335%
Ventana Medical Systems, Inc.305%
Bio Sb, Inc.274%

Top labelers

CompanyDevicesShare
Richard-Allan Scientific Company16126%
Remel, Inc.7612%
Calibrescientific Us, Inc.528%
Transene Company, Inc.498%
Scientific Device Laboratory, Inc.366%
Leica Biosystems Richmond, Inc.335%
Ventana Medical Systems, Inc.305%
Bio Sb, Inc.274%
Becton, Dickinson And Company234%
Diagnostic Biosystems, Inc.224%
Fertipro Nv122%
Siemens Healthcare Diagnostics Inc.102%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Congo Red Stain Core KitSpecial Stains Nuclear Fast Red CSGMS Stain Core KitSpecial Stains Van Gieson CSElastic Stain Core KitSpecial Stains Eosin CSJones Stain Core KitBenchMark Special Stains AFB Staining KitBioSci™Artisan Alpha AmylaseVitalScreen Reagent 2VitalScreen Reagent 1Spermac Stain - Fix (250ml)Spermac Stain - Stain C (250ml)Spermac Stain - Stain B (250ml)Spermac Stain - Stain A (250ml)

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

FDA product codes

CodeNameDevices
JTSStains, Microbiologic111
HYJHematoxylin41
PPMGeneral Purpose Reagent38
LEDStains, Chemical Solution35
HYFGiemsa Stain28
HZJStain, Papanicolau26

GMDN & GCC registration

  • GMDN code 43587 · non‑implantable
  • Single‑use 48% · sterile 0% · Rx‑only 13% · 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 (Fluid Ounce) · 80Total Volume (Gallon) · 44Total Volume (Quart) · 44Total Volume (Pint) · 40Total Volume (Milliliter) · 37

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How many biological stain ivd products are registered in the US?

620 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biological stain IVD", from 35 companies. The largest labeler is Richard-Allan Scientific Company with 26% of records.

Which FDA product codes apply?

JTS (Stains, Microbiologic), HYJ (Hematoxylin), PPM (General Purpose Reagent), LED (Stains, Chemical Solution)

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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