Albumin -BCG method TC-Matrix A502-510TM

GUDID 10673486001020

The Albumin -BCG method TC-Matrix is used for the quantitative determination of Albumin in serum or plasma on TC-Matrix analyzers

TECO DIAGNOSTICS

Albumin IVD, reagent

• Primary Device ID: 10673486001020
• NIH Device Record Key: 738855a2-12bc-4e2c-8a12-ffd958692e2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Albumin -BCG method TC-Matrix
• Version Model Number: A502-510TM
• Catalog Number: A502-510TM
• Company DUNS: 185067774
• Company Name: TECO DIAGNOSTICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com
• Phone: 7144631111
• Email: hello@tecodiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875070

FDA Product Code

• CIX: Bromcresol Green Dye-Binding, Albumin

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: 2023-07-17
• Device Publish Date: 2023-07-07

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