MassTrak 186010566IVD

GUDID 00816776020575

MassTrak™ Steroid Serum QC Set 3

WATERS TECHNOLOGIES CORPORATION

Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control Multiple steroid hormone IVD, control

• Primary Device ID: 00816776020575
• NIH Device Record Key: c22fdade-7e3d-4731-882a-d0697c148dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MassTrak
• Version Model Number: 186010566IVD
• Catalog Number: 186010566IVD
• 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
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816776020575 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2023-12-13
• Device Publish Date: 2023-12-05

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