Alkaline Phosphatase (Kinetic Procedure) A505-400

GUDID 10673486001068

The Alkaline Phosphatase (Kinetic Procedure) is used for the quantitative determination of alkaline phosphatase in human serum.

TECO DIAGNOSTICS

Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent Total alkaline phosphatase (ALP) IVD, reagent

• Primary Device ID: 10673486001068
• NIH Device Record Key: e347e80c-dbb9-48ba-8253-0fb80b9b6802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alkaline Phosphatase (Kinetic Procedure)
• Version Model Number: A505-400
• Catalog Number: A505-400
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10673486001068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864905

FDA Product Code

• CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Alkaline Phosphatase (Kinetic Procedure)]

• 10673486001068: The Alkaline Phosphatase (Kinetic Procedure) is used for the quantitative determination of alkal
• 10673486001051: The Alkaline Phosphatase (Kinetic Procedure) is used for the quantitative determination of alkal