CD117/c-kit

GUDID 00847627007643

BIOCARE MEDICAL LLC

CD117 (c-kit) cell marker IVD, antibody

• Primary Device ID: 00847627007643
• NIH Device Record Key: ee5147fd-395f-4651-830d-f2dab7827f1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD117/c-kit
• Version Model Number: CME296BK
• 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: true
• 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	00847627007643 [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 [CD117/c-kit]

• 00847627029386: ALI296G7
• 00847627024565: OPAI296T60
• 00847627011985: PME296AA
• 00847627008701: IP296G10
• 00847627007650: CME296CK
• 00847627007643: CME296BK
• 00847627007636: CME296AK
• 00847627038685: NPAI296T40