General-microorganism antimicrobial susceptibility culture medium IVD — 263 US-registered devices, 4 companies, FDA product codes | Device Explorer

Name: General-microorganism antimicrobial susceptibility culture medium IVD — US-registered devices
Creator: Consulting Wallah
License: https://creativecommons.org/licenses/by-nc-nd/4.0/

Share of device records

Remel, Inc.13752%

Beckman Coulter, Inc.7428%

Biomerieux , Inc.5119%

Avails Medical, Inc.10%

Top labelers

Company	Devices	Share
Remel, Inc.	137	52%
Beckman Coulter, Inc.	74	28%
Biomerieux , Inc.	51	19%
Avails Medical, Inc.	1	0%

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

Brand names on the register (sample)

VITEK® 2 AST-N816VITEK® 2 AST-N815VITEK® 2 AST-N814VITEK® 2 AST-XN33VITEK® 2 AST-N813VITEK® 2 AST-N812VITEK® 2 AST-N811VITEK® 2 AST-N810VITEK® 2 AST-N808VITEK® 2 AST-N807VITEK® 2 AST-N806VITEK® 2 AST-N809VITEK® 2 AST-XN32VITEK® 2 AST-XN31VITEK® 2 AST-XN30VITEK® 2 AST-N804

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

FDA product codes

Code	Name	Devices
JSG	Culture Media, Non-Selective And Non-Differential	202
JWY	Manual Antimicrobial Susceptibility Test Systems	70
LTT	Panels, Test, Susceptibility, Antimicrobial	69
LRG	Instrument For Auto Reader & Interpretation Of Overnight Sus	68
LTW	Susceptibility Test Cards, Antimicrobial	61
LON	System, Test, Automated, Antimicrobial Susceptibility, Short	42

GMDN & GCC registration

GMDN code 58605 · non‑implantable
Single‑use 48% · sterile 0% · Rx‑only 44% · 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.

Basic/simple nutrient agar culture medium IVD85 devices · 8 companies

How many general-microorganism antimicrobial susceptibility culture medium ivd products are registered in the US?

263 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-microorganism antimicrobial susceptibility culture medium IVD", from 4 companies. The largest labeler is Remel, Inc. with 52% of records.

Which FDA product codes apply?

JSG (Culture Media, Non-Selective And Non-Differential), JWY (Manual Antimicrobial Susceptibility Test Systems), LTT (Panels, Test, Susceptibility, Antimicrobial), LRG (Instrument For Auto Reader & Interpretation Of Overnight Sus)

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.