AccuTrak

GUDID 00850011135709

AccuTrak aTSHR Calibration Verification Panel

Lgc Clinical Diagnostics, Inc.

Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

• Primary Device ID: 00850011135709
• NIH Device Record Key: d040c480-e39b-4671-9f49-0ebd9565da37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuTrak
• Version Model Number: 2400-0255
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011135709 [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: 2025-01-15
• Device Publish Date: 2025-01-07

On-Brand Devices [AccuTrak]

• 00850011135655: AccuTrak sFlt-1 Calibration Verification Panel
• 00850011135693: AccuTrak aTPO Calibration Verification Panel
• 00850011135709: AccuTrak aTSHR Calibration Verification Panel
• 00850011135686: AccuTrak aTG Calibration Verification Panel
• 00850011135815: AccuTrak T-Uptake Calibration Verification Panel
• 00850011135792: AccuTrak Abeta42 Calibration Verification Panel