BioCode MDx 3000 Optical Calibration and Verification Kit

Basic Information

• Brand Name: BioCode MDx 3000 Optical Calibration and Verification Kit
• Primary DI: 00851034007028
• Version / Model: 1
• Catalog Number: 64-C0002
• Company Name: APPLIED BIOCODE, INC.
• Labeler DUNS: 004580003
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-30
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 173408ab-db29-415f-8001-4ff3bb7a9b14

Device Description

Kit containing calibrators and controls for MDx 3000.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• 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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
61061	Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator	A material which is used to establish known points of reference for as assay intended to be used for the quantitative and/or qualitative detection of nucleic acid from multiple types of pathogens associated with gastrointestinal disease, in a clinical specimen. 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	00851034007028	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius