PD-L1

GUDID 00847627003430

BIOCARE MEDICAL LLC

Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-ligand 1 (PD-L1) IVD, kit, enzyme immunohistochemistry Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody Programmed death-1 (PD-1) IVD, antibody

• Primary Device ID: 00847627003430
• NIH Device Record Key: 363d7ab6-98b8-4e0f-9200-5c392e4b0d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PD-L1
• Version Model Number: ACI3171C
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00847627003430 [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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [PD-L1]

• 00847627029027: AVI3171G
• 00847627025289: OPAI3171T60
• 00847627004567: API3171AA
• 00847627003430: ACI3171C
• 00847627003423: ACI3171A
• 00847627034083: ALI3171G7