BioCode MDx 3000 41-A0051

GUDID 00851034007004

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

APPLIED BIOCODE, INC.

Microplate reader IVD, automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated Microplate reader IVD, automated/semi-automated

• Primary Device ID: 00851034007004
• NIH Device Record Key: 85a52091-6381-461b-a61c-ae3f412836bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCode MDx 3000
• Version Model Number: 1
• Catalog Number: 41-A0051
• 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: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com
• Phone: 5628010050
• Email: tpham@apbiocode.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851034007004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180041

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2018-11-15
• Device Publish Date: 2018-10-15

Devices Manufactured by APPLIED BIOCODE, INC.

• 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: 2018-11-15The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) 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