Consulting Wallah › Device Explorer › IVD & laboratory › Multiple Salmonella species antigen IVD, control
Device Explorer · FDA GUDID · GMDN 51519

Multiple Salmonella species antigen IVD, control

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria in a clinical specimen.

US‑registered devices65in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Ssi Diagnostica A/S6295%
Becton, Dickinson And Company35%

Top labelers

CompanyDevicesShare
Ssi Diagnostica A/S6295%
Becton, Dickinson And Company35%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Salm. Multi Gr. Poly A-67 serum, 3 mLSalm. H Phase Pool H:G - H:m,t serum;1 mLS. Virchow reference strainS. Typhimurium reference strainS. Stanley reference strainS. Senftenberg reference strainS. Saintpaul reference strainS. Paratyphi A reference strainS. Newport reference strainS. Montevideo reference strainS. Infantis reference strainS. Heidelberg reference strainS. Hadar reference strainS. Enteritidis reference strainS. Derby reference strainS. Braenderup reference strain

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.57
GRLAntigens, All Groups, Salmonella Spp.15
GRLANTIGENS, ALL GROUPS, SALMONELLA SPP.13
GRMANTISERA, ALL GROUPS, SALMONELLA SPP.2

GMDN & GCC registration

  • GMDN code 51519 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 5% · 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) · 13

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

How many multiple salmonella species antigen ivd, control products are registered in the US?

65 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, control", from 2 companies. The largest labeler is Ssi Diagnostica A/S with 95% of records.

Which FDA product codes apply?

GRM (Antisera, All Groups, Salmonella Spp.), GRL (Antigens, All Groups, Salmonella Spp.), GRL (ANTIGENS, ALL GROUPS, SALMONELLA SPP.), 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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