Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005967741

FEI Number

3005967741

Entity Name

BIOARRAY SOLUTIONS LIMITED

City/State/Country

Warren, NJ, US

Establishment Address

35 Technology Dr Ste 100, Warren, NJ 07059, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

BioArray Solutions Limited (Owner Number: 10041491)

Owner / Operator Contact Address

35 Technology Drive, Suite 100, Warren, NJ 07059, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioArray Array Imaging System (AIS) 400C Array Imaging System AIS400C PreciseType HEA BeadCheck Kit HPA BeadChip Test Kit HEA 1.2 BeadChip Test Kit RHCE BeadChip Test Kit RHD BeadChip Test Kit MIA FORA NGS MFlex 11 HLA Typing Kit (24,96 &1152) MIA FORA NGS MFlex 6 HLA Typing Kit (24,96 &1152)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2014-08-18
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2012-07-30
PFK	Quality Control For Molecular Immunohematology Tests	Hematology	Class 2	864.9650	2014-08-18
MAO	Dna-Probe, Human Chromosome	Unknown	Class U	N/A	2012-07-30
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2024-11-14

Official Correspondent

Jesdeep Sidhu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioArray Solutions Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005967741. Last updated year: 2026. Please use registration number 3005967741 when referencing this establishment in official correspondence.