Gastrointestinal Pathogen Panel (GPP) Kit

GUDID 00851034007011

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

APPLIED BIOCODE, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00851034007011
• NIH Device Record Key: f7228397-ce95-4208-a64b-771fc91e01b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gastrointestinal Pathogen Panel (GPP) Kit
• Version Model Number: 1
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@apbiocode.com
• Phone: 562-801-0050
• Email: tpham@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	00851034007011 [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.

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• 00851034007011 - Gastrointestinal Pathogen Panel (GPP) Kit: 2018-11-15In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
• 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.
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