Teco Diagnostics HDL Cholesterol Reagent Set H511-20

GUDID 10673486001884

Teco Diagnostics HDL Cholesterol Reagent Set is used for the quantitative determination of high density lipoprotein (HDL) in human serum.

TECO DIAGNOSTICS

High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent High density lipoprotein (HDL) cholesterol IVD, reagent

• Primary Device ID: 10673486001884
• NIH Device Record Key: 8ec7d3d2-ffe8-42e0-8faf-498be440942b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics HDL Cholesterol Reagent Set
• Version Model Number: H511-20
• Catalog Number: H511-20
• 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	10673486001884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880176

FDA Product Code

• LBR: Ldl & Vldl Precipitation, Hdl

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: 2023-11-20
• Device Publish Date: 2023-11-10

On-Brand Devices [Teco Diagnostics HDL Cholesterol Reagent Set]

• 10673486001884: Teco Diagnostics HDL Cholesterol Reagent Set is used for the quantitative determination of high
• 10673486001938: Teco Diagnostics HDL Cholesterol Reagent Set is used for the quantitative determination of high