Gastrointestinal Pathogen Panel (GPP) Kit

Basic Information

• Brand Name: Gastrointestinal Pathogen Panel (GPP) Kit
• Primary DI: 00851034007011
• Version / Model: 1
• Company Name: APPLIED BIOCODE, INC.
• Labeler DUNS: 004580003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-15
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: f7228397-ce95-4208-a64b-771fc91e01b9

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	2
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	866.3990	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61058	Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851034007011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180041	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -10 Degrees Celsius