Consulting Wallah › Device Explorer › IVD & laboratory › Multiple bacteria species culture isolate identifi
Device Explorer · FDA GUDID · GMDN 61331

Multiple bacteria species culture isolate identification control IVD, kit

A collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a

US‑registered devices1,428in commercial distribution
Companies4labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Microbiologics Inc.1,40899%
Oxoid Limited181%
Elitech Microbio10%
Biomerieux Sa10%

Top labelers

CompanyDevicesShare
Microbiologics Inc.1,40899%
Oxoid Limited181%
Elitech Microbio10%
Biomerieux Sa10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OXIDASE STRIPSMICROBACT LISTERIA 12L HAEMOLYSIN REAGENTMicrobact Staph Fast Blue ReagentMicrobact Staph 12SREAGENT SPOT INDOLE DMACAMICROBACT PROGRAM FOR WINDOWSMICROBACT GNB 12B STRIP (60 ID'S)MICROBACT GNB 12A STRIP (60 ID'S)MICROBACT GNB 24E TRAY (40 ID'S)MICROBACT MINERAL OILMICROBACT REAGENT SET DMICROBACT REAGENT INDOLE - KOVACSMICROBACT REAGENT NITRATE BMICROBACT REAGENT NITRATE AMICROBACT REAGENT VP IIMICROBACT REAGENT VP I

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

FDA product codes

CodeNameDevices
JTRKIT, QUALITY CONTROL FOR CULTURE MEDIA1,617
OHQMulti-analyte controls unassayed13
JTODiscs, Strips And Reagents, Microorganism Differentiation8
LQMGram Negative Identification Panel4
LIBDevice, General Purpose, Microbiology, Diagnostic3
LQLGram Positive Identification Panel3

GMDN & GCC registration

  • GMDN code 61331 · non‑implantable
  • Single‑use 99% · 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 bacteria species culture isolate identification control ivd, kit products are registered in the US?

1,428 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple bacteria species culture isolate identification control IVD, kit", from 4 companies. The largest labeler is Microbiologics Inc. with 99% of records.

Which FDA product codes apply?

JTR (KIT, QUALITY CONTROL FOR CULTURE MEDIA), OHQ (Multi-analyte controls unassayed), JTO (Discs, Strips And Reagents, Microorganism Differentiation), LQM (Gram Negative Identification Panel)

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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