Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) G571-150

GUDID 10673486001839

Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) is used for the quantitative determination of gamma-GT in human serum.

TECO DIAGNOSTICS

Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent Gamma-glutamyltransferase (GGT) IVD, reagent

• Primary Device ID: 10673486001839
• NIH Device Record Key: 41d07f19-7f6c-4edb-9a43-2b504f9ad2d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)
• Version Model Number: G571-150
• Catalog Number: G571-150
• 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	10673486001839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881626

FDA Product Code

• JQB: Kinetic Method, Gamma-Glutamyl Transpeptidase

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: 2023-11-14
• Device Publish Date: 2023-11-06

On-Brand Devices [Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)]

• 10673486001846: Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) is used for the
• 10673486001839: Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate) is used for the