Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007799234

FEI Number

3007799234

Entity Name

Applied BioCode, Inc.

City/State/Country

Santa Fe Springs, CA, US

Establishment Address

12130 Mora Drive Unit #2, Santa Fe Springs, CA 90670, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Applied BioCode, Inc. (Owner Number: 10029149)

Owner / Operator Contact Address

12130 Mora Drive Unit #2, 10370 Slusher Drive Unit #2-7, Santa Fe Springs, CA 90670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180041

PMA Number

N/A

All Registered Proprietary Names

BioCode MDx-3000 BioCode SARS-CoV-2 Assay BioCode CoV-2 Flu Plus Assay BioCode Aspergillus fumigatus BMB-Probe BioCode Rhizopus microsporus BMB-Probe BioCode Fusarium solani BMB-Probe BioCode Candida lusitaniae BMB-Probe BioCode Pneumocystis jirovecii BMB-Probe BioCode Blastomyces dermatitidis BMB-Probe BioCode Rhizopus spp. BMB-Probe BioCode Aspergillus terreus BMB-Probe BioCode Fungal ITS2 Primer Pair BioCode Cunninghamella bertholletiae BMB-Probe BioCode Fusarium oxysporum BMB-Probe BioCode Rhizomucor spp. BMB-Probe BioCode Scedosporium prolificans BMB-Probe BioCode Pneumocystis jirovecii Primer Pair BioCode Aspergillus niger BMB-Probe BioCode Candida parapsilosis BMB-Probe BioCode Aspergillus flavus BMB-Probe BioCode Scedosporium apiospermum BMB-Probe BioCode Mucor indicus BMB-Probe BioCode Candida albicans BMB-Probe BioCode Candida auris BMB-Probe BioCode Rhizopus oryzae BMB-Probe BioCode Candida dubliniensis BMB-Probe BioCode Histoplasma capsulatum BMB-Probe BioCode Candida glabrata BMB-Probe BioCode Candida guilliermondii BMB-Probe BioCode Cryptococcus spp. BMB-Probe BioCode Candida tropicalis BMB-Probe BioCode Candida krusei BMB-Probe BioCode Coccidioides spp. BMB-Probe BioCode DNA-IC Pack BioCode Respiratory Pathogen Panel Gastrointestinal Pathogen Panel (GPP) Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2020-05-22
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2020-06-17
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2021-07-27
OLD	Internal Polymerase Chain Reaction Control, Not Assay Specific	Clinical Chemistry	Class 1	862.1660	2021-07-27
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2020-01-08
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay	Microbiology	Class 2	866.3980	2020-01-08
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	Class 2	866.3980	2020-01-08
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2020-01-08
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2020-01-08
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2020-01-08
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2020-01-08
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2020-01-08
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2020-01-08
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	Class 2	866.3980	2020-01-08
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2018-10-08
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2018-10-08

Official Correspondent

Pushpinder Marshall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Applied BioCode, Inc.

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-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 3007799234. Last updated year: 2026. Please use registration number 3007799234 when referencing this establishment in official correspondence.