CD138 + Cyclin D1

GUDID 00847627004703

BIOCARE MEDICAL LLC

Multiple solid tumour differentiation marker IVD, antibody

• Primary Device ID: 00847627004703
• NIH Device Record Key: f0dc1a45-b259-406f-b20b-0b1e668f0aff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD138 + Cyclin D1
• Version Model Number: API3193DSAA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627004703 [Primary]

FDA Product Code

• FDA: Enteroscope And Accessories

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: 2023-06-29
• Device Publish Date: 2023-06-21

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• 00847627036582 - SOX10 (M): 2024-08-23
• 00847627033673 - intelliPATH MAX: 2024-07-25
• 00847627033796 - intelliPATH MAX: 2024-07-25
• 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