Consulting Wallah › Device Explorer › IVD & laboratory › Assay container IVD, single-use
Device Explorer · FDA GUDID · GMDN 62225

Assay container IVD, single-use

A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or

US‑registered devices1,148in commercial distribution
Companies28labelers on GUDID
Single‑use47%of device records
Sterile15%labelled sterile
Prescription53%Rx‑only share
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Share of device records

Ventana Medical Systems, Inc.58651%
Sarstedt Aktiengesellschaft & Co.Kg42937%
Globe Scientific Inc.323%
Porex Corporation182%
Siemens Healthcare Diagnostics Inc.131%
Euroimmun Medizinische Labordiagnostika Ag101%
Agilent Technologies, Inc.61%
Fisher Scientific Company L.L.C.61%

Top labelers

CompanyDevicesShare
Ventana Medical Systems, Inc.58651%
Sarstedt Aktiengesellschaft & Co.Kg42937%
Globe Scientific Inc.323%
Porex Corporation182%
Siemens Healthcare Diagnostics Inc.131%
Euroimmun Medizinische Labordiagnostika Ag101%
Agilent Technologies, Inc.61%
Fisher Scientific Company L.L.C.61%
Bio/Data Corporation61%
Abbott Molecular Inc.50%
Cardinal Health 200, Llc50%
Leica Biosystems Newcastle Ltd40%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ASSY RGT DSPNR CARD BMK PREP KIT 325ASSY RGT DSPNR CARD BMK PREP KIT 324ASSY RGT DSPNR CARD BMK PREP KIT 323ASSY RGT DSPNR CARD BMK PREP KIT 322ASSY RGT DSPNR CARD BMK PREP KIT 321ASSY RGT DSPNR CARD BMK PREP KIT 320ASSY RGT DSPNR CARD BMK PREP KIT 319ASSY RGT DSPNR CARD BMK PREP KIT 318ASSY RGT DSPNR CARD BMK PREP KIT 317ASSY RGT DSPNR CARD BMK PREP KIT 316ASSY RGT DSPNR CARD BMK PREP KIT 315ASSY RGT DSPNR CARD BMK PREP KIT 314ASSY RGT DSPNR CARD BMK PREP KIT 313ASSY RGT DSPNR CARD BMK PREP KIT 312ASSY RGT DSPNR CARD BMK PREP KIT 311ASSY RGT DSPNR CARD BMK PREP KIT 310

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

FDA product codes

CodeNameDevices
JRCMICRO PIPETTE586
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE292
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE177
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 68
KDTContainer, Specimen Mailer And Storage, Sterile21
NNKContainer, Specimen Mailer And Storage, Non-Sterile15

GMDN & GCC registration

  • GMDN code 62225 · non‑implantable
  • Single‑use 47% · sterile 15% · Rx‑only 53% · OTC 1%
  • 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) · 6

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

How many assay container ivd, single-use products are registered in the US?

1,148 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Assay container IVD, single-use", from 28 companies. The largest labeler is Ventana Medical Systems, Inc. with 51% of records.

Which FDA product codes apply?

JRC (MICRO PIPETTE), NNK (CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE), KDT (CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE), LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted )

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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