VALIDATE

GUDID 00850011135662

VALIDATE B-CTx Calibration Verification/Linearity Test Kit

Lgc Clinical Diagnostics, Inc.

Collagen type I cross-linked C-telopeptide IVD, control

• Primary Device ID: 00850011135662
• NIH Device Record Key: 8dcbaea9-8702-4972-9662-61ef15a2b242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALIDATE
• Version Model Number: 304re
• Company DUNS: 075886031
• Company Name: Lgc Clinical Diagnostics, Inc.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com
• Phone: 1-800-377-9684
• Email: MSC.info@LGCGroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011135662 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2024-05-27
• Device Publish Date: 2024-05-17

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