ARC – Antigen Retrieval Chamber

GUDID 00847627030887

BIOCARE MEDICAL LLC

Pressurized incubator IVD

• Primary Device ID: 00847627030887
• NIH Device Record Key: 15ff6e44-a4d9-4b0f-b8a2-ccedcbc0a8e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARC – Antigen Retrieval Chamber
• Version Model Number: DCARC0001-R
• Company DUNS: 806617825
• Company Name: BIOCARE MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627030887 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-03

On-Brand Devices [ARC – Antigen Retrieval Chamber]

• 00847627030887: DCARC0001-R
• 00847627030870: DCARC0001