Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028746593

FEI Number

3028746593

Entity Name

BIOTEKE USA LLC

City/State/Country

Miami, FL, US

Establishment Address

900 Brickell Key Blvd Suite 2304, Miami, FL 33131, US

Establishment Type(s)

Repack or Relabel Medical Device,Remanufacture Medical Device,Reprocess Single-Use Device

Owner / Operator

Bioteke USA LLC (Owner Number: 10088753)

Owner / Operator Contact Address

900 Brickell Key Blvd Suite 2304, Miami, FL 33131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bio-Self COVID-19 Antigen Home Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2023-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioteke USA LLC

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-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028746593. Last updated year: 2026. Please use registration number 3028746593 when referencing this establishment in official correspondence.