Consulting Wallah › Device Explorer › IVD & laboratory › General specimen container IVD, additive/medium
Device Explorer · FDA GUDID · GMDN 63232

General specimen container IVD, additive/medium

A covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of

US‑registered devices116in commercial distribution
Companies18labelers on GUDID
Single‑use74%of device records
Sterile16%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Hangzhou Bioer Technology Co., Ltd.2925%
Copan Italia Spa2320%
Fisher Scientific Company L.L.C.1311%
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.87%
Mawi Dna Technologies, Llc65%
Puritan Medical Products65%
Huachenyang (Shenzhen) Technology Co., Ltd65%
Shenzhen Dakewe Bio-Engineering Co., Ltd54%

Top labelers

CompanyDevicesShare
Hangzhou Bioer Technology Co., Ltd.2925%
Copan Italia Spa2320%
Fisher Scientific Company L.L.C.1311%
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.87%
Mawi Dna Technologies, Llc65%
Puritan Medical Products65%
Huachenyang (Shenzhen) Technology Co., Ltd65%
Shenzhen Dakewe Bio-Engineering Co., Ltd54%
Coopersurgical, Inc.54%
Merit Medical Systems, Inc.43%
Magbio Genomics, Inc.33%
Aero-Med, Llc22%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BabioBIOER Viral Transport MediumBIOER Sample Preservative FluidBioSci™TransFixCultura™cobas PCR MediaRNARetainColor Urine Collection KitMagbio Genomics, Inc.Mawi DNA TechnologiesT-CupAero-MedFisherbrandERPeakEmbryo Biopsy Kit

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

FDA product codes

CodeNameDevices
JSMCulture Media, Non-Propagating Transport51
NNKContainer, Specimen Mailer And Storage, Non-Sterile44
JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT19
LIODevice, Specimen Collection7
QBDMicrobial Nucleic Acid Storage And Stabilization Device6
PPMGeneral Purpose Reagent6

GMDN & GCC registration

  • GMDN code 63232 · non‑implantable
  • Single‑use 74% · sterile 16% · Rx‑only 38% · OTC 13%
  • 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) · 1

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How many general specimen container ivd, additive/medium products are registered in the US?

116 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General specimen container IVD, additive/medium", from 18 companies. The largest labeler is Hangzhou Bioer Technology Co., Ltd. with 25% of records.

Which FDA product codes apply?

JSM (Culture Media, Non-Propagating Transport), NNK (Container, Specimen Mailer And Storage, Non-Sterile), JSM (CULTURE MEDIA, NON-PROPAGATING 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.

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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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