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Device Explorer · FDA GUDID · GMDN 57940

Oral/upper respiratory tract specimen collection swab

A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal

US‑registered devices93in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile92%labelled sterile
Prescription18%Rx‑only share
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Share of device records

Hlb Co.,Ltd3639%
Applied Medical Resources Corporation910%
Bioteke Corporation (Wuxi) Co., Ltd.78%
Zhejiang Renon Medical Instrument Co., Ltd.66%
Shenzhen Dakewe Bio-Engineering Co., Ltd66%
Merit Medical Systems, Inc.66%
Abiogenix Inc55%
Medico Technology Co., Ltd33%

Top labelers

CompanyDevicesShare
Hlb Co.,Ltd3639%
Applied Medical Resources Corporation910%
Bioteke Corporation (Wuxi) Co., Ltd.78%
Zhejiang Renon Medical Instrument Co., Ltd.66%
Shenzhen Dakewe Bio-Engineering Co., Ltd66%
Merit Medical Systems, Inc.66%
Abiogenix Inc55%
Medico Technology Co., Ltd33%
Miraclean Technology Co., Ltd.33%
Typenex Medical Llc33%
Dna Genotek Inc33%
Rhinostics Inc22%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RENONMEDMEIDIKE GENEBioTekeSNT BiotechBiosci™Saliva Collection KitDisposable Sampling SwabBaaySCI Disposable Nasal SwabCultura™Lattice SwabAbiogenix FAST Spiral Nasopharyngeal SwabMolecular Testing LabsRhinostics, Inc.Kashi ScientificAnterior Nasal SwabSpecimen Collection Swab

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

FDA product codes

CodeNameDevices
KXGApplicator, Absorbent Tipped, Sterile92
KXGAPPLICATOR, ABSORBENT TIPPED, STERILE5
KXFApplicator, Absorbent Tipped, Non-Sterile3
OYJDna Specimen Collection, Saliva2
NNKContainer, Specimen Mailer And Storage, Non-Sterile1
KXGApplicator, absorbent tipped, sterile1

GMDN & GCC registration

  • GMDN code 57940 · non‑implantable
  • Single‑use 100% · sterile 92% · Rx‑only 18% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 9Length (Millimeter) · 7Depth (Millimeter) · 5

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

How many oral/upper respiratory tract specimen collection swab products are registered in the US?

93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Oral/upper respiratory tract specimen collection swab", from 16 companies. The largest labeler is Hlb Co.,Ltd with 39% of records.

Which FDA product codes apply?

KXG (Applicator, Absorbent Tipped, Sterile), KXG (APPLICATOR, ABSORBENT TIPPED, STERILE), KXF (Applicator, Absorbent Tipped, Non-Sterile), OYJ (Dna Specimen Collection, Saliva)

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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