BioCode Respiratory Pathogen Panel 63-R0001

GUDID 00851034007073

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

APPLIED BIOCODE, INC.

Multiple respiratory pathogen nucleic acid IVD, control

• Primary Device ID: 00851034007073
• NIH Device Record Key: 86169df7-c0b5-496c-8036-508b9418e7f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCode Respiratory Pathogen Panel
• Version Model Number: 01
• Catalog Number: 63-R0001
• Company DUNS: 004580003
• Company Name: APPLIED BIOCODE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com
• Phone: 8332462633
• Email: atang@apbiocode.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851034007073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192485

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

Devices Manufactured by APPLIED BIOCODE, INC.

• 00851034007073 - BioCode Respiratory Pathogen Panel: 2020-01-20In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
• 00851034007073 - BioCode Respiratory Pathogen Panel: 2020-01-20 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
• 00851034007028 - BioCode MDx 3000 Optical Calibration and Verification Kit: 2019-08-07 Kit containing calibrators and controls for MDx 3000.
• 00851034007035 - BioCode MDx 3000 Buffer A: 2019-08-07 Buffer used in MDx 3000 assays.
• 00851034007042 - BioCode SA-PE Mix Pack: 2019-08-07 Fluorescence dye for MDx 3000 assays.
• 00851034007004 - BioCode MDx 3000: 2018-11-15 The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB)
• 00851034007011 - Gastrointestinal Pathogen Panel (GPP) Kit: 2018-11-15 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
• 00851034007059 - BioCode 2500 Multiplex Detection System: 2018-09-24 The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magneti