Cytokeratin HMW

GUDID 00847627037855

BIOCARE MEDICAL LLC

Cytokeratin IVD, antibody

• Primary Device ID: 00847627037855
• NIH Device Record Key: 79a68a43-7fd2-4da2-8c33-911623a18f63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytokeratin HMW
• Version Model Number: NPAI127T80
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627037855 [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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Cytokeratin HMW ]

• 00847627037855: NPAI127T80
• 00847627037848: NPAI127T40