ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) A525-400

GUDID 10673486001112

The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of alanine aminotransferase in human serum.

TECO DIAGNOSTICS

Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent Alanine aminotransferase (ALT) IVD, reagent

• Primary Device ID: 10673486001112
• NIH Device Record Key: 781be17a-eb03-4bae-8adc-61a115a0b102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)
• Version Model Number: A525-400
• Catalog Number: A525-400
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864906

FDA Product Code

• CKA: Nadh Oxidation/Nad Reduction, Alt/Sgpt

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: 2023-07-25
• Device Publish Date: 2023-07-17

On-Brand Devices [ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)]

• 10673486001112: The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of ala
• 10673486001105: The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of ala