Teco Diagnostics Glucose (Oxidase) Reagent Set G519-1L

GUDID 10673486001723

Teco Diagnostics Glucose (Oxidase) Reagent Set is used for the quantitative determination of total glucose in human serum.

TECO DIAGNOSTICS

Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent Glucose IVD, reagent

• Primary Device ID: 10673486001723
• NIH Device Record Key: 3fd4aca0-55ef-40a8-a3ad-c0f55b2ae884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics Glucose (Oxidase) Reagent Set
• Version Model Number: G519-1L
• Catalog Number: G519-1L
• 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: 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 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	10673486001723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863926

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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 Glucose (Oxidase) Reagent Set]

• 10673486001723: Teco Diagnostics Glucose (Oxidase) Reagent Set is used for the quantitative determination of tot
• 10673486001716: Teco Diagnostics Glucose (Oxidase) Reagent Set is used for the quantitative determination of tot