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Device Explorer · FDA GUDID · GMDN 65196

General specimen collection kit

A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions fo

US‑registered devices309in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile57%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Copan Italia Spa12139%
Centurion Medical Products Corporation4916%
Aero-Med, Llc3311%
Chengdu Rich Science Industry Co., Ltd.217%
Puritan Medical Products176%
Remel, Inc.165%
Medline Industries, Inc.114%
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.72%

Top labelers

CompanyDevicesShare
Copan Italia Spa12139%
Centurion Medical Products Corporation4916%
Aero-Med, Llc3311%
Chengdu Rich Science Industry Co., Ltd.217%
Puritan Medical Products176%
Remel, Inc.165%
Medline Industries, Inc.114%
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.72%
Therapak Llc62%
Jinan Babio Biotechnology Co., Ltd.52%
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.41%
C. R. Bard, Inc.41%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BabioMacro & Micro-Test Sample Collecting, Mailing & Sample Preparation System (Stool)VYGONkidneyintelX.dkd Single Tube Specimen CollectionRenalytixAI Urine Collection KitKidneyIntelX Blood Collection Convenience KitLiquid Stuarts,Wire Shaft PK/50Liquid Stuarts,Wire Shaft Swab PK/100Liquid Stuarts,Dual Swab PK/50Liquid Stuarts,Dual Swab PK/500Liquid Stuarts,Single Swab PK/50Liquid Stuarts,Single Swab PK/500Liquid Amies,Dual Swab PK/50Amies Charcoal Gel,Single Swab PK/50Amies Clear Gel,Wire Shaft PK/50

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

FDA product codes

CodeNameDevices
OIBBlood and urine collection kit (excludes HIV testing)99
JSMCulture Media, Non-Propagating Transport91
JSLCulture Media, Anaerobic Transport30
LIODevice, Specimen Collection28
JSGCulture Media, Non-Selective And Non-Differential28
JTWSystem, Transport, Aerobic27

GMDN & GCC registration

  • GMDN code 65196 · non‑implantable
  • Single‑use 100% · sterile 57% · Rx‑only 72% · OTC 10%
  • 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) · 8Catheter Gauge (French) · 4Length (Millimeter) · 4Height (Millimeter) · 1

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

How many general specimen collection kit products are registered in the US?

309 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General specimen collection kit", from 19 companies. The largest labeler is Copan Italia Spa with 39% of records.

Which FDA product codes apply?

OIB (Blood and urine collection kit (excludes HIV testing)), JSM (Culture Media, Non-Propagating Transport), JSL (Culture Media, Anaerobic Transport), LIO (Device, Specimen Collection)

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.

How do I get quotes?

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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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