Ber-EP4

GUDID 00847627011008

BIOCARE MEDICAL LLC

Epithelial antigen IVD, antibody

• Primary Device ID: 00847627011008
• NIH Device Record Key: 8b074479-d29c-4dd9-86df-d205d974de76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ber-EP4
• Version Model Number: PM107AA
• 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	00847627011008 [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 [Ber-EP4]

• 00847627025371: OPAI107T60
• 00847627008619: IP107G10
• 00847627029423: ALI107G7
• 00847627024886: AVI107G
• 00847627011015: PM107H
• 00847627011008: PM107AA
• 00847627038760: NPAI107T80
• 00847627038753: NPAI107T40