Teco Diagnostics Cholesterol Reagent Set C509-1L

GUDID 10673486001471

Teco Diagnostics Cholesterol Reagent Set is used for the quantitative determination of total cholesterol in human serum.

TECO DIAGNOSTICS

Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent Total cholesterol lipid IVD, reagent

• Primary Device ID: 10673486001471
• NIH Device Record Key: f13d8a1e-059a-4418-8e2a-1b81870889d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Cholesterol Reagent Set
• Version Model Number: C509-1L
• Catalog Number: C509-1L
• 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: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com
• Phone: 714-463-1111
• Email: hello@tecodiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863927

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

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: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [Teco Diagnostics Cholesterol Reagent Set]

• 10673486001471: Teco Diagnostics Cholesterol Reagent Set is used for the quantitative determination of total cho
• 10673486001464: Teco Diagnostics Cholesterol Reagent Set is used for the quantitative determination of total cho
• 10673486001457: Teco Diagnostics Cholesterol Reagent Set is used for the quantitative determination of total cho