Applied BioCode, Inc.

Registration Details

Registration Name: Applied BioCode, Inc.
Registration Number: 3007799234
FEI Number: 3007799234
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 12130 Mora Drive Unit #2
City: Santa Fe Springs
State: CA
ZIP: 90670
Country: US

Regulatory Submissions

510(k) Number: K192485

Owner / Operator

Firm Name: Applied BioCode, Inc.
Operator Number: 10029149
Address: 12130 Mora Drive Unit #2, 10370 Slusher Drive Unit #2-7
City: Santa Fe Springs
State: CA
Postal Code: 90670
Country: US
Correspondent: Pushpinder K Marshall

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Real Time Nucleic Acid Amplification System	OOI	Class 2	Clinical Chemistry	No	2020-05-22
Respiratory Virus Panel Nucleic Acid Assay System	OCC	Class 2	Microbiology	No	2020-06-17
Reagents, Specific, Analyte	MVU	Class 1	Pathology	No	2021-07-27
Internal Polymerase Chain Reaction Control, Not Assay Specific	OLD	Class 1	Clinical Chemistry	No	2021-07-27
Mycoplasma Pneumoniae Dna Assay System	OZX	Class 2	Microbiology	No	2020-01-08
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	Class 2	Microbiology	No	2020-01-08
Bordetella Pertussis Dna Assay System	OZZ	Class 2	Microbiology	No	2020-01-08
Instrumentation For Clinical Multiplex Test Systems	NSU	Class 2	Clinical Chemistry	No	2020-01-08
Parainfluenza Multiplex Nucleic Acid Assay	OOU	Class 2	Microbiology	No	2020-01-08
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	Class 2	Microbiology	No	2020-01-08
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	Class 2	Microbiology	No	2020-01-08
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	Class 2	Microbiology	No	2020-01-08
Chlamydophila Pneumoniae Dna Assay System	OZY	Class 2	Microbiology	No	2020-01-08
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	Class 2	Microbiology	No	2018-10-08
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	Class 1	Clinical Chemistry	No	2017-05-22

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 BioCode 2500 Multiplex Detection System BioCode Gastrointestinal Pathogen Panel (GPP)

Establishment Types

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