Probe Enhancer (RNA)

Basic Information

• Brand Name: Probe Enhancer (RNA)
• Primary DI: 00847627035875
• Version / Model: BRI6024G10
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-02
• Public Version: 1
• Public Version Date: 2024-07-10
• Public Version Status: New
• Public Device Record Key: c10157cb-c056-417a-a9c9-c2040925d398

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62691	Molecular grade buffered sample diluent IVD	A molecular grade buffered solution intended to be used as a diluent for a clinical specimen, reagent and/or other substances used prior to, or during an assay using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627035875	GS1

Storage Conditions

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