Immco

GUDID 05391516747493

Wash Buffer Concentrate

CLARK LABORATORIES, INC.

Buffered wash solution IVD, manual

• Primary Device ID: 05391516747493
• NIH Device Record Key: da4ba67a-d308-4ac9-89e1-c8619eac5f9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immco
• Version Model Number: 230AWI
• Company DUNS: 623214079
• Company Name: CLARK LABORATORIES, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com

Device Dimensions

• Total Volume: 60 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516747493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954723

FDA Product Code

• LKJ: Antinuclear Antibody, Antigen, Control

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: 2020-01-07
• Device Publish Date: 2019-12-30

Devices Manufactured by CLARK LABORATORIES, INC.

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• 05391516747455 - Trinity Biotech: 2020-01-08 System Verify Dye Test for automated analyzers
• 05391516746588 - Bio-Stat: 2020-01-07 Syphilis EIA (Non-US sales only)
• 05391516747424 - Phoenix Biotech: 2020-01-07 Trep Sure Bulk Kit
• 05391516747493 - Immco: 2020-01-07Wash Buffer Concentrate
• 05391516747493 - Immco: 2020-01-07 Wash Buffer Concentrate
• 05391516746519 - Trinity Biotech: 2020-01-06 Wash Buffer Concentrate Type I, 20X
• 05391516746526 - Trinity Biotech: 2020-01-06 Stop Solution