Decloaking Chamber™ NxGen

Basic Information

• Brand Name: Decloaking Chamber™ NxGen
• Primary DI: 00847627023506
• Version / Model: DC2012
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: d042e18c-9d62-45aa-8025-d91b1f56ab54

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPA	Slide Stainer, Automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66288	Pressurized incubator IVD	An electrically-powered pressurized heating chamber intended to be used for the incubation of laboratory specimens for subsequent in vitro diagnostic procedures [e.g., heat-induced epitope retrieval (HIER) and deparaffinization for immunohistochemistry]. It is typically in the form of a pot, similar to a pressure cooker, with a lid and a removable inner liner, where samples are placed in a holder or tray for heating. It is programmable with dedicated software to control settings for temperature, pressure, and incubation time.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847627023506	GS1