BioCode SA-PE Mix Pack

Basic Information

• Brand Name: BioCode SA-PE Mix Pack
• Primary DI: 00851034007042
• 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: 2019-07-30
• Public Version: 1
• Public Version Date: 2019-08-07
• Public Version Status: New
• Public Device Record Key: 46d5c808-17b6-48e8-9e84-0e8705e320e6

Device Description

Fluorescence dye for MDx 3000 assays.

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
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851034007042	GS1

Customer Contacts

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