VALIDATE THY2

GUDID 00850011135600

VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).

Lgc Clinical Diagnostics, Inc.

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

• Primary Device ID: 00850011135600
• NIH Device Record Key: d62b627b-b81d-4b94-bb38-8928c9282456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALIDATE THY2
• Version Model Number: 908ro
• 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: 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: 1-800-377-9684
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011135600 [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: 2023-06-14
• Device Publish Date: 2023-06-06

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