CD3 [LN10]

GUDID 00847627004376

BIOCARE MEDICAL LLC

CD3 cell marker IVD, antibody

• Primary Device ID: 00847627004376
• NIH Device Record Key: a7b6275d-0a3f-4143-b47b-9579c3d1efc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD3 [LN10]
• Version Model Number: API3152AA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847627004376 [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 [CD3 [LN10]]

• 00847627004383: API3152H
• 00847627004376: API3152AA
• 00847627003331: ACI3152C
• 00847627003324: ACI3152A
• 00847627037084: NPAI3152T40
• 00847627042941: NPAI3152T80