Cytokeratin LMW (8/18)

GUDID 00847627037961

BIOCARE MEDICAL LLC

Cytokeratin IVD, antibody

• Primary Device ID: 00847627037961
• NIH Device Record Key: 97e50c26-397c-4bf8-b756-b3abc6a0a676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytokeratin LMW (8/18)
• Version Model Number: NPAI056T80
• 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	00847627037961 [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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [Cytokeratin LMW (8/18)]

• 00847627031754: OPAI056T60
• 00847627028167: ALI056G7
• 00847627008848: IPI056G10
• 00847627037961: NPAI056T80
• 00847627037954: NPAI056T40