Probe Enhancer (RNA)

GUDID 00847627035875

BIOCARE MEDICAL LLC

Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD Molecular grade buffered sample diluent IVD

• Primary Device ID: 00847627035875
• NIH Device Record Key: c10157cb-c056-417a-a9c9-c2040925d398
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe Enhancer (RNA)
• Version Model Number: BRI6024G10
• 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: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627035875 [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: 2024-07-10
• Device Publish Date: 2024-07-02

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627035493 - ARCHV – Antigen Retrieval Chamber High Voltage: 2024-07-10
• 00847627035509 - ARCHV – Antigen Retrieval Chamber High Voltage (Recertified): 2024-07-10
• 00847627035875 - Probe Enhancer (RNA): 2024-07-10
• 00847627035875 - Probe Enhancer (RNA): 2024-07-10
• 00847627024121 - KI-67 [MIB-1]: 2024-07-05
• 00847627035653 - RISH™ RNA Positive Control Probe: 2024-06-07
• 00847627035677 - RISH™ RNA Negative Control Probe: 2024-06-07
• 00847627035851 - Helicobacter pylori [EPR10353]: 2024-05-31
• 00847627033604 - intelliPATH MAX: 2024-05-08