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Device Explorer · FDA GUDID · GMDN 58567

Cell culture medium IVD

A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

US‑registered devices180in commercial distribution
Companies12labelers on GUDID
Single‑use38%of device records
Sterile29%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Lonza Verviers5732%
Diagnostic Hybrids, Inc.4123%
Lonza Walkersville, Inc.2514%
Incell Corporation, Llc1810%
Life Technologies Corporation137%
Irvine Scientific, Llc127%
Shanghai Beijin Biotechnological Co., Ltd32%
Clark Laboratories, Inc.32%

Top labelers

CompanyDevicesShare
Lonza Verviers5732%
Diagnostic Hybrids, Inc.4123%
Lonza Walkersville, Inc.2514%
Incell Corporation, Llc1810%
Life Technologies Corporation137%
Irvine Scientific, Llc127%
Shanghai Beijin Biotechnological Co., Ltd32%
Clark Laboratories, Inc.32%
Oxford Immunotec Limited21%
Vericel Corporation21%
Vitrolife Inc.21%
Life Technologies Limited21%

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

Brand names on the register (sample)

Shanghai BeijinIMDM w/25mM HEPES wo PR or L-Gln, 1LIMDM w/25mM HEPES wo PR or L-Gln 20L bagDMEM w/ Gluc, HEPES, L-Gln w/o PR - 25LIMDM Powder w/o HEPES, PR L-Glut, 1000LEMEM w/o L-Glut NaHCO3,NaH2PO4,PR 1000LSF5-16 med. with Pluronic Biograde -Sup2SF5-16 med. with Pluronic Biograde - 5LSF5-16 med. with Pluronic Biograde -Sup1SF5-16 med. with Pluronic Biograde -500LPowerCHO-GS powder - 5LPowerCHO-2 CD - 500ml sample bagLONZA MEDIUM BASE 1 - 100 gLONZA MEDIUM BASE 1 - 20 kgLONZA MEDIUM BASE 1 - 50 gLONZA MEDIUM BASE 1 - 504.39 g

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

FDA product codes

CodeNameDevices
KITMEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE175
KITMedia And Components, Synthetic Cell And Tissue Culture131
KIPFORMULATIONS, BALANCED SALT SOLUTIONS53
KIPFormulations, Balanced Salt Solutions18
KIQKIT, CULTURE, CHROMOSOME7
NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL5

GMDN & GCC registration

  • GMDN code 58567 · non‑implantable
  • Single‑use 38% · sterile 29% · Rx‑only 40% · 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) · 21

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

How many cell culture medium ivd products are registered in the US?

180 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cell culture medium IVD", from 12 companies. The largest labeler is Lonza Verviers with 32% of records.

Which FDA product codes apply?

KIT (MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE), KIT (Media And Components, Synthetic Cell And Tissue Culture), KIP (FORMULATIONS, BALANCED SALT SOLUTIONS), KIP (Formulations, Balanced Salt Solutions)

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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