Evidence MultiSTAT EV4115

GUDID 05055273214970

The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories.

RANDOX LABORATORIES LIMITED

Multiplex analyser IVD, laboratory

• Primary Device ID: 05055273214970
• NIH Device Record Key: 0d00f40e-fe41-482d-8efa-2ad1d2111c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evidence MultiSTAT
• Version Model Number: EV4115
• Catalog Number: EV4115
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273214970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220451

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2024-09-23
• Device Publish Date: 2024-09-13

Devices Manufactured by RANDOX LABORATORIES LIMITED

• 05055273210101 - Liquid Immunoassay Control – Level 1 (IA CONTROL 1): 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
• 05055273210118 - LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2): 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
• 05055273210125 - LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3): 2025-04-01 The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH V
• 05055273219814 - PTH CONTROL LEVEL 1 (PTH CONTROL 1): 2025-04-01 The PTH Control Level 1 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
• 05055273219821 - PTH CONTROL LEVEL 2 (PTH CONTROL 2): 2025-04-01 The PTH Control Level 2 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
• 05055273219838 - PTH CONTROL LEVEL 3 (PTH CONTROL 3): 2025-04-01 The PTH Control Level 3 is intended for use with in vitro diagnostic immunoassays for the quantitative determination of Parathyr
• 05055273219043 - LIQUID CARDIAC CONTROL 1: 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig
• 05055273219050 - LIQUID CARDIAC CONTROL 2: 2025-03-31 The Liquid Cardiac Controls are intended for use with in vitro diagnostic assays for the quantitative determination of CKMB, Hig