APPLIED BIOCODE, INC.

APPLIED BIOCODE, INC.

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

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Real Time Nucleic Acid Amplification System (OOI) (2) Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System (PCH) (2) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Human Metapneumovirus (Hmpv) Rna Assay System (OEM) (1) Influenza A And Influenza B Multiplex Nucleic Acid Assay (OZE) (1) Influenza A Virus Subtype Differentiation Nucleic Acid Assay (OEP) (1) Instrumentation For Clinical Multiplex Test Systems (NSU) (1) Mycoplasma Pneumoniae Dna Assay System (OZX) (1) Non-Sars Coronavirus Multiplex Nucleic Acid Assay (OTG) (1) Parainfluenza Multiplex Nucleic Acid Assay (OOU) (1) Bordetella Pertussis Dna Assay System (OZZ) (1) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1) Chlamydophila Pneumoniae Dna Assay System (OZY) (1)

Premarket Exempt

No Yes

Clear

BioCode MDx 3000 - 00851034007004 Catalog Number : 41-A0051

Device Description : The BioCode MDx 3000 is an automated molecular diagnostic system for use with Ap The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.

Device Class : 2

Duns Number: 004580003

Premarket Exempt : No

Product Code : OOI, PCH

Prescription Use : Yes

Device Count : 1

Gastrointestinal Pathogen Panel (GPP) Kit - 00851034007011 Catalog Number :

Device Description : In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gas In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.

Device Class : 2

Duns Number: 004580003

Premarket Exempt : No

Product Code : OOI, PCH

Prescription Use : Yes

Device Count : 1

BioCode MDx 3000 Optical Calibration and Verification Kit - 00851034007028 Catalog Number : 64-C0002

Device Description : Kit containing calibrators and controls for MDx 3000.

Device Class :

Duns Number: 004580003

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

BioCode MDx 3000 Buffer A - 00851034007035 Catalog Number :

Device Description : Buffer used in MDx 3000 assays.

Device Class :

Duns Number: 004580003

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

BioCode SA-PE Mix Pack - 00851034007042 Catalog Number :

Device Description : Fluorescence dye for MDx 3000 assays.

Device Class :

Duns Number: 004580003

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

BioCode 2500 Multiplex Detection System - 00851034007059 Catalog Number : 41-A0005

Device Description : The BioCode 2500 Multiplex Detection System is a digital optics imaging system f The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) technology.

Device Class : 1

Duns Number: 004580003

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : No

Device Count : 1

BioCode Respiratory Pathogen Panel - 00851034007073 Catalog Number : 63-R0001

Device Description : In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of res In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.

Device Class : 2

Duns Number: 004580003

Premarket Exempt : No

Product Code : NSU, OZZ, OZY, OZX, OTG, OOU, OEM, OEP, OZE, OCC

Prescription Use : Yes

Device Count : 1

Previous 1 Next