Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2086993

FEI Number

3003059701

Entity Name

RANDOX LABORATORIES-US, LTD

City/State/Country

Kearneysville, WV, US

Establishment Address

515 INDUSTRIAL BOULEVARD, JEFFERSON COUNTY, Kearneysville, WV 25430, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

RANDOX LABORATORIES, LTD. (Owner Number: 8020890)

Owner / Operator Contact Address

55 DIAMOND RD., --, CRUMLIN, CO.ANTRIM, GB-NOTA BT29 4QY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ESSENTIAL PACKAGE SAMPLE COLLECTION KIT (USA) ConcizuTrace Sample Collection Kit EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA) EXTENDED PACKAGE SAMPLE COLLECTION KIT (USA U60) BASELINE Venous Sample Collection Kit BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit MALE HORMONE Premium Home Blood Sampling Collection Kit BIOHACKER Premium Home Blood Sampling Collection Kit FEMALE HORMONE Premium Home Blood Sampling Collection Kit PlaySafe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2023-07-31
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2024-09-30

Official Correspondent

Karena Shaw

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RANDOX LABORATORIES, LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014607865	RANDOX LABORATORIES LIMITED	ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB
3009473156	Randox Teoranta	Dungloe Donegal, IE
3004493545	RANDOX LABORATORIES LIMITED	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2086993. Last updated year: 2026. Please use registration number 2086993 when referencing this establishment in official correspondence.