Consulting Wallah › Device Explorer › IVD & laboratory › Evacuated blood collection tube IVD, clot activato
Device Explorer · FDA GUDID · GMDN 41128

Evacuated blood collection tube IVD, clot activator/separator

A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of bl

US‑registered devices55in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Guangzhou Improve Medical Instruments Co., Ltd.2138%
Becton, Dickinson And Company1527%
Greiner Bio-One Gmbh1425%
Becton, Dickinson U.K. Limited35%
Quest Diagnostics12%
Kb Medical (Group), Inc.12%

Top labelers

CompanyDevicesShare
Guangzhou Improve Medical Instruments Co., Ltd.2138%
Becton, Dickinson And Company1527%
Greiner Bio-One Gmbh1425%
Becton, Dickinson U.K. Limited35%
Quest Diagnostics12%
Kb Medical (Group), Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

K-QUE-SAR-SHIPPERBD® Quincke Spinal NeedlesBD Vacutainer® Serum 10.0 mLBD Vacutainer® Serum 6.0mLBD Vacutainer® SST™BD Vacutainer® SST™ Blood Collection TubeBD Vacutainer® SST™ II AdvanceVACUETTEVacuetteIMPROVACUTER® Gel & Clot Activator TubeKBMED

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

FDA product codes

CodeNameDevices
JKATubes, vials, systems, serum separators, blood collection40
JKATubes, Vials, Systems, Serum Separators, Blood Collection23
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1

GMDN & GCC registration

  • GMDN code 41128 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 62% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 7Total Volume (Milliliter) · 7Needle Gauge (Gauge) · 1Length (Inch) · 1

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

How many evacuated blood collection tube ivd, clot activator/separator products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Evacuated blood collection tube IVD, clot activator/separator", from 6 companies. The largest labeler is Guangzhou Improve Medical Instruments Co., Ltd. with 38% of records.

Which FDA product codes apply?

JKA (Tubes, vials, systems, serum separators, blood collection), JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), BSP (NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER))

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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