HER2/ER/PR IHControls® BRLS11

GUDID 00850045519001

HER2/ER/PR IHControls® - Level H are immunostaining positive controls for diagnostic immunohistochemistry laboratories. The same immunohistochemical reaction that occurs on a tissue or cellular sample also occurs on the HER2/ER/PR IHControls® microbead. As a result of immunostaining, the microbead bearing the analyte turns the same color as cells expressing the analyte.

Boston Cell Standards Inc

C-erbB2/Her2/neu oncoprotein IVD, control

• Primary Device ID: 00850045519001
• NIH Device Record Key: f9f1c3c4-7aa8-425f-9962-e4e3a8ded10e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HER2/ER/PR IHControls®
• Version Model Number: Level H
• Catalog Number: BRLS11
• Company DUNS: 126775860
• Company Name: Boston Cell Standards Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045519001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220163

FDA Product Code

• NJW: Control Material, Her-2/Neu, Immunohistochemistry

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: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [HER2/ER/PR IHControls®]

• 00850045519025: HER2/ER/PR IHControls® - Level L are immunostaining positive controls for diagnostic immunohist
• 00850045519018: HER2/ER/PR IHControls® - Level M are immunostaining positive controls for diagnostic immunohist
• 00850045519001: HER2/ER/PR IHControls® - Level H are immunostaining positive controls for diagnostic immunohist