ALP AP311

GUDID 05055273200324

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum o

RANDOX LABORATORIES LIMITED

Alkaline phosphatase (ALP) isoenzyme IVD, reagent

• Primary Device ID: 05055273200324
• NIH Device Record Key: 823a22dd-93b2-4281-bf78-8b7172d7a3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALP
• Version Model Number: AP311
• Catalog Number: AP311
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• 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: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stable for 1 week at +2 to +8°C or 1 day at +15 to +25°C once R1a and R1b reconstituted
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273200324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923507

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [ALP]

• 05055273200393: An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determina
• 05055273200362: An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determina
• 05055273200348: An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determina
• 05055273200331: An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determina
• 05055273200324: An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determina
• 05055273200300: The ALP method used on the Dimension clinical chemistry system is an in vitro diagnostic test in