Consulting Wallah › Device Explorer › IVD & laboratory › Platelet aggregation study IVD, reagent
Device Explorer · FDA GUDID · GMDN 56092

Platelet aggregation study IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, whic

US‑registered devices51in commercial distribution
Companies9labelers on GUDID
Single‑use59%of device records
Sterile0%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Chrono-Log Corp1427%
Helena Laboratories Corporation1224%
Haemonetics Corporation816%
Bio/Data Corporation510%
Accriva Diagnostics Holdings, Inc.48%
Siemens Healthcare Diagnostics Products Gmbh36%
Zacros Corporation24%
Aggredyne, Inc.24%

Top labelers

CompanyDevicesShare
Chrono-Log Corp1427%
Helena Laboratories Corporation1224%
Haemonetics Corporation816%
Bio/Data Corporation510%
Accriva Diagnostics Holdings, Inc.48%
Siemens Healthcare Diagnostics Products Gmbh36%
Zacros Corporation24%
Aggredyne, Inc.24%
Analytical Control Systems Inc12%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PL ChipPL Chip for T-TAS 01AggreguideAggreDYNE AA AssayDade® PFA Trigger SolutionDade® PFA Collagen/ADP Test CartridgeDade® PFA Collagen/EPI Test CartridgeSlide Platelet Aggregation Test ReagentCHRONO-PARChrono-logTEG5000 HEMOSTASIS SYSTEMPlateletworks Arachidonic Acid KitPlateletworks Collagen KitPlateletworks ADP KitPlateletworks Combo-10 KitPlateletworks Combo-25 Kit

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

FDA product codes

CodeNameDevices
JOZSYSTEM, AUTOMATED PLATELET AGGREGATION17
JOZSystem, Automated Platelet Aggregation13
GGPTest, Qualitative And Quantitative Factor Deficiency6
GHRReagent, Platelet Aggregation5
GHRREAGENT, PLATELET AGGREGATION5
GFOActivated Partial Thromboplastin1

GMDN & GCC registration

  • GMDN code 56092 · non‑implantable
  • Single‑use 59% · sterile 0% · Rx‑only 90% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many platelet aggregation study ivd, reagent products are registered in the US?

51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Platelet aggregation study IVD, reagent", from 9 companies. The largest labeler is Chrono-Log Corp with 27% of records.

Which FDA product codes apply?

JOZ (SYSTEM, AUTOMATED PLATELET AGGREGATION), JOZ (System, Automated Platelet Aggregation), GGP (Test, Qualitative And Quantitative Factor Deficiency), GHR (Reagent, Platelet Aggregation)

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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