CD20 [L26]

GUDID 00847627005410

BIOCARE MEDICAL LLC

CD20 cell marker IVD, antibody

• Primary Device ID: 00847627005410
• NIH Device Record Key: 008a79b5-b621-4b0c-a0be-8c3d485ab4fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD20 [L26]
• Version Model Number: CM004B
• 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	00847627005410 [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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [CD20 [L26]]

• 00847627029508: ALI004G7
• 00847627024411: OPAI004T60
• 00847627010599: PM004H
• 00847627010582: PM004AA
• 00847627008435: IP004G20
• 00847627008428: IP004G10
• 00847627005427: CM004C
• 00847627005410: CM004B
• 00847627005403: CM004A
• 00847627038180: NPAI004T80
• 00847627038173: NPAI004T40