Verax Biomedical Incorporated

FDA Device Registration & Listing · Westborough, MA, US · Registration 3005935106

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005935106
FEI Number
3005935106
Entity Name
Verax Biomedical Incorporated
City/State/Country
Westborough, MA, US
Establishment Address
2200 West Park Drive Suite 300, Westborough, MA 01581, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Verax Biomedical Incorporated (Owner Number: 10023050)
Owner / Operator Contact Address
2200 West Park Drive Suite 300, Westborough, MA 01581, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Platelet PGDprime Controls Platelet PGDprime Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2020-12-02
MZC System, Detection, Bacterial, For Platelet Transfusion Products Microbiology Class 1 866.2560 2008-04-04

Official Correspondent

Nancy Hornbaker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Verax Biomedical Incorporated
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04

Similar Registrations

Registration Number Establishment Name Location
3005706626 Bioptik Technology, Inc. Jhunan Township Miaoli, TW
3002642396 Ortho Clinical Diagnostics Singapore South West, SG
2050010 BECKMAN COULTER, INC. CARLSBAD, CA, US
3008156187 TECHNO-PATH MANUFACTURING LTD. Ballina Tipperary, IE
2016706 Bio-Rad Laboratories Inc. IRVINE, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005935106. Last updated year: 2026. Please use registration number 3005935106 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.