Potassium (K) PT3852

GUDID 05055273204933

For the quantitative in vitro determination of Potassium in serum or plasma.

RANDOX LABORATORIES LIMITED

Potassium (K+) IVD, reagent

• Primary Device ID: 05055273204933
• NIH Device Record Key: ee0c061d-ae29-4037-905d-8e28a1275a87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Potassium (K)
• Version Model Number: PT3852
• Catalog Number: PT3852
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273204933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043267

FDA Product Code

• CEJ: Tetraphenyl Borate, Colorimetry, Potassium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Potassium (K)]

• 05055273204940: For the quantitative in vitro determination of Potassium in serum or plasma.
• 05055273204933: For the quantitative in vitro determination of Potassium in serum or plasma.