MassTrak 186010253IVD

GUDID 00816776020537

MassTrak™ Immunosuppressant Internal Standard Set

WATERS TECHNOLOGIES CORPORATION

Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

• Primary Device ID: 00816776020537
• NIH Device Record Key: 26dab142-963b-4447-8d2a-b9015868ebd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MassTrak
• Version Model Number: 186010253IVD
• Catalog Number: 186010253IVD
• Company DUNS: 107186004
• Company Name: WATERS TECHNOLOGIES CORPORATION
• 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: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com
• Phone: 1-800-252-4752
• Email: customerservice@waters.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816776020537 [Primary]

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2022-04-13
• Device Publish Date: 2022-04-05

On-Brand Devices [MassTrak]

• 00816776020438: MassTrak™ Endocrine Steroid Quality Control Set
• 00816776020421: MassTrak™ Endocrine Steroid Calibrator Set
• 00816776020292: MassTrak TDM C18 2.1x10mm Column, IVD
• 00816776020537: MassTrak™ Immunosuppressant Internal Standard Set
• 00816776020520: MassTrak™ Immunosuppressant Quality Control Set
• 00816776020513: MassTrak™ Immunosuppressant Calibrator Set
• 00816776020599: MassTrak™ Steroid Internal Standard Mix
• 00816776020582: MassTrak™ Steroid Optimization Mix
• 00816776020575: MassTrak™ Steroid Serum QC Set 3
• 00816776020568: MassTrak™ Steroid Serum Cal Set 3
• 00816776020551: MassTrak™ Steroid Serum QC Set 2
• 00816776020544: MassTrak™ Steroid Serum Cal Set 2
• 00816776020247: MassTrak Endocrine Blank Calibrator