MACH 2 Universal HRP Polymer Detection

GUDID 00847627009104

BIOCARE MEDICAL LLC

Immunohistochemistry antibody detection IVD, reagent

• Primary Device ID: 00847627009104
• NIH Device Record Key: 0af9f54a-df4d-4620-a93b-57f5603fd425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MACH 2 Universal HRP Polymer Detection
• Version Model Number: M2U522L
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627009104 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [MACH 2 Universal HRP Polymer Detection]

• 00847627009104: M2U522L
• 00847627009098: M2U522H
• 00847627009081: M2U522G
• 00847627036667: M2U522MM