CD4 + CD8

GUDID 00847627034953

BIOCARE MEDICAL LLC

Multiple solid tumour differentiation marker IVD, antibody

• Primary Device ID: 00847627034953
• NIH Device Record Key: d21aff8e-2667-4772-96a3-435deda4d071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD4 + CD8
• Version Model Number: OPAI3157DS
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627034953 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [CD4 + CD8]

• 00847627004437: API3157DSAA
• 00847627034953: OPAI3157DS