PREMIER MEDICAL USA CORPORATION

FDA Device Registration & Listing · Somerset, NJ, US · Registration 3017013438

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
3017013438
FEI Number
3017013438
Entity Name
PREMIER MEDICAL USA CORPORATION
City/State/Country
Somerset, NJ, US
Establishment Address
27 Schoolhouse Rd, Somerset, NJ 08873, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Premier Medical USA Corporation (Owner Number: 10080215)
Owner / Operator Contact Address
27 Schoolhouse Rd, Somerset, NJ 08873, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sure Status Syphilis Anti-TP Card Test Sure Status HIV 1+2/ Syphilis Combo Card Test Sure Status HIV-1 Recency Card Test Sure Status HIV 1-2 Card Test Sure Status HBsAg Card Test Sure Status Malaria Antigen Pf/PAN Combo Card Test Sure Status Dengue (NS1) Card Test Sure Status HCV Card Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MTN Test, Syphilis, Treponemal Unknown Class N N/A 2023-07-31
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2023-07-31
KSJ System, Identification, Hepatitis B Antigen Unknown Class 3 N/A 2023-07-31
OAX Plasmodium Spp. Detection Reagents Microbiology Class 2 866.3402 2023-07-31
QCU Dengue Virus Antigen Assay Microbiology Class 2 866.3945 2023-07-31
OBF Assay, Genotyping, Hepatitis C Virus Microbiology Class 2 866.3170 2023-07-31

Official Correspondent

Matthew Soens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Premier Medical USA Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017013438. Last updated year: 2026. Please use registration number 3017013438 when referencing this establishment in official correspondence.
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