Consulting Wallah › Device Explorer › IVD & laboratory › Multiple Salmonella species antigen IVD, kit, rapi
Device Explorer · FDA GUDID · GMDN 65291

Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Salmonella bacteria in a clinical specimen and/or culture isolate within a short period, r

US‑registered devices77in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Pro-Lab, Incorporated77100%

Top labelers

CompanyDevicesShare
Pro-Lab, Incorporated77100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Monovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - Z4 ComMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - FactorMonovalent Flagella Salmonella Antisera - Factor

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

FDA product codes

CodeNameDevices
GRMAntisera, All Groups, Salmonella Spp.77

GMDN & GCC registration

  • GMDN code 65291 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 0% · 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.

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

How many multiple salmonella species antigen ivd, kit, rapid agglutination, clinical products are registered in the US?

77 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical", from 1 companies. The largest labeler is Pro-Lab, Incorporated with 100% of records.

Which FDA product codes apply?

GRM (Antisera, All Groups, Salmonella Spp.)

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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