Gross Cystic Disease Fluid Protein-15 (GCDFP-15)

GUDID 00847627041586

BIOCARE MEDICAL LLC

Gross cystic disease fluid protein-15 IVD, antibody

• Primary Device ID: 00847627041586
• NIH Device Record Key: 6caf90eb-15d5-4da4-852b-522a128c0ab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gross Cystic Disease Fluid Protein-15 (GCDFP-15)
• Version Model Number: NPAI113T40
• 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	00847627041586 [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: 2025-09-02
• Device Publish Date: 2025-08-25

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627040312 - Melan A (M): 2025-09-02
• 00847627040329 - Melan A (M): 2025-09-02
• 00847627041586 - Gross Cystic Disease Fluid Protein-15 (GCDFP-15): 2025-09-02
• 00847627041586 - Gross Cystic Disease Fluid Protein-15 (GCDFP-15): 2025-09-02
• 00847627041630 - PRAME [EPR20330]: 2025-08-26
• 00847627041692 - Hepatocyte Specific Antigen (HSA): 2025-08-26
• 00847627041715 - Tumor Associated Glycoprotein [B72.3]: 2025-08-26
• 00847627041180 - INSM1 [BLR272L]: 2025-08-18
• 00847627041463 - CD8: 2025-08-18