BRAF V600E [VE1]

GUDID 00847627027122

BIOCARE MEDICAL LLC

Serine/threonine-protein kinase B-raf IVD, antibody

• Primary Device ID: 00847627027122
• NIH Device Record Key: 586b3422-f4da-4561-b3c1-8587f1804844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAF V600E [VE1]
• Version Model Number: AVI3248G
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627027122 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-09
• Device Publish Date: 2022-12-12

Devices Manufactured by BIOCARE MEDICAL LLC

• 00847627027122 - BRAF V600E [VE1]: 2025-06-09
• 00847627027122 - BRAF V600E [VE1]: 2025-06-09
• 00847627035790 - TTF-1 [SPT24]: 2025-06-02
• 00847627038951 - NeoPATH Pro Universal AP Polymer Kit: 2025-06-02
• 00847627036247 - Treponema pallidum (Spirochete): 2025-05-26
• 00847627039620 - Arginase-1: 2025-05-26
• 00847627040213 - CD3 T-Cell: 2025-05-15
• 00847627040466 - Helicobacter pylori [EPR10353]: 2025-04-28
• 00847627040473 - Helicobacter pylori [EPR10353]: 2025-04-28