CD39 [EPR20627

GUDID 00847627030542

BIOCARE MEDICAL LLC

Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody

• Primary Device ID: 00847627030542
• NIH Device Record Key: 0c101bbe-98f3-4284-bf0b-3c29ef50cca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD39 [EPR20627
• Version Model Number: ACI3283C
• 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

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00847627030542 [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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by BIOCARE MEDICAL LLC

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• 00847627035509 - ARCHV – Antigen Retrieval Chamber High Voltage (Recertified): 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