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Device Explorer · FDA GUDID · GMDN 58177

Urine specimen collection kit IVD

A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tu

US‑registered devices216in commercial distribution
Companies30labelers on GUDID
Single‑use99%of device records
Sterile14%labelled sterile
Prescription8%Rx‑only share
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Share of device records

Aero-Med, Llc10950%
Avaline Medical Nj Limited Liability Company3617%
Cardinal Health 200, Llc115%
Dna Genotek Inc52%
Fisher Scientific Company L.L.C.52%
Richard-Allan Scientific Company42%
Greiner Bio-One Gmbh42%
Medline Industries, Inc.42%

Top labelers

CompanyDevicesShare
Aero-Med, Llc10950%
Avaline Medical Nj Limited Liability Company3617%
Cardinal Health 200, Llc115%
Dna Genotek Inc52%
Fisher Scientific Company L.L.C.52%
Richard-Allan Scientific Company42%
Greiner Bio-One Gmbh42%
Medline Industries, Inc.42%
Boddingtons Plastics Limited31%
Medfire Innovations Inc.31%
Becton, Dickinson And Company31%
Medzah Industries31%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sample Processing kits for Urine/Fecal AnalysisMedflyPeezy Non-sterile specimen mailer and storage coNon-sterile specimen mailer and storage containePlaySafe™Urine Raku-Ryu CupTri-Tech Forensics, Inc.UroMap Specimen Collection KitRTL Urine Collection KitUS Biotek LaboratoriesGenova DiagnosticsAmerican Hospital SupplyAvaline Medical NJ LLCLetsGetChecked Urine Sample Collection Kit (UACRLetsGetChecked Urine Sample Collection Kit (SM02Recopad

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)178
FMHCONTAINER, SPECIMEN, STERILE32
NNICONTAINER, SPECIMEN, NON-STERILE18
OIEUrine Collection Kit (Excludes Hiv Testing)15
JXAKIT, SCREENING, URINE14
OIEUrine collection kit (excludes HIV testing)9

GMDN & GCC registration

  • GMDN code 58177 · non‑implantable
  • Single‑use 99% · sterile 14% · Rx‑only 8% · OTC 61%
  • 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 (Fluid Ounce) · 2Height (Inch) · 1Width (Inch) · 1Length (Inch) · 1

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

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

216 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urine specimen collection kit IVD", from 30 companies. The largest labeler is Aero-Med, Llc with 50% of records.

Which FDA product codes apply?

OIB (Blood and urine collection kit (excludes HIV testing)), FMH (CONTAINER, SPECIMEN, STERILE), NNI (CONTAINER, SPECIMEN, NON-STERILE), OIE (Urine Collection Kit (Excludes Hiv Testing))

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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