Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010749841

FEI Number

3010749841

Entity Name

BIOGX

City/State/Country

Birmingham, AL, US

Establishment Address

2450 Valleydale Rd, Birmingham, AL 35244, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioGX (Owner Number: 10054546)

Owner / Operator Contact Address

2450 Valleydale Rd, Birmingham, AL 35244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioGX - Candida Speciation GATPK - OSR for BD MAX BioGX - Candida-Trichomonas - OSR for BD MAX BioGX - Mycobacterium tuberculosis Complex - OSR for BD MAX BioGX - Viral Meningitis HSV/VZV - OSR for BD MAX BioGX - Bacterial Meningitis ELGBS - OSR for BD MAX BioGX - Bacterial Meningitis NSH - OSR for BD MAX BioGX - Mycoplasma-Ureaplasma - OSR for BD MAX BioGX - Pneumocystis jirovecii - OSR for BD MAX BioGX - Flu A, Flu B, RSV A/B - OSR for BD MAX BioGX - Vancomycin Resistance - OSR for BD MAX BioGX - vanA/B - OSR for BD MAX BioGX - Lesion HSVHD - OSR for BD MAX BioGX - Syphilis - OSR for BD MAX BioGX - Bordetella Speciation Plus Toxin - OSR for BD MAX BioGX - Bordetella pertussis/parapertussis - OSR for BD MAX BioGX - Group A Streptococcus - OSR for BD MAX Xfree COVID-19 Direct RT-PCR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PII	Candida Species Nucleic Acid Detection System	Microbiology	Class 2	866.3960	2026-03-18
QBH	Lower Respiratory Microbial Nucleic Acid Detection System	Microbiology	Class 2	866.3985	2026-03-18
PLO	Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	Microbiology	Class 2	866.3970	2026-03-18
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2026-03-18
PEO	Fungal Organisms, Nucleic Acid-Based Assay	Microbiology	Class 2	866.3365	2026-03-18
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2026-03-18
PAM	Gram-Positive Bacteria And Their Resistance Markers	Microbiology	Class 2	866.3365	2026-03-18
PGI	Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	Microbiology	Class 2	866.3309	2026-03-18
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2026-03-18
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2017-05-04
OYZ	Group A Streptococcus Nucleic Acid Amplification Assay System	Microbiology	Class 1	866.3740	2026-03-18
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-11-19

Official Correspondent

Christopher Hughes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioGX

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-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010749841. Last updated year: 2026. Please use registration number 3010749841 when referencing this establishment in official correspondence.