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

• 00847627038913 - HMW CK + p63 (Basal Cell Cocktail): 2025-08-04
• 00847627039927 - E-cadherin: 2025-08-04
• 00847627039965 - CK5/14 + p63 + P504S: 2025-08-04
• 00847627040176 - CK5/14 + p63 + P504S: 2025-08-04
• 00847627041340 - Cytokeratin 5 (CK5): 2025-08-04
• 00847627041425 - p63 + CK5: 2025-08-04
• 00847627038999 - Cytokeratin 20 (CK20): 2025-07-29
• 00847627039002 - Cytokeratin 20 (CK20): 2025-07-29