CAL A RX4000

GUDID 05055273206098

The product is intended to be used as a wash solution and single point calibrator. Calibrator A is pumped into the sample port by the Calibrator A pu

RANDOX LABORATORIES LIMITED

Multiple clinical chemistry analyte IVD, calibrator

• Primary Device ID: 05055273206098
• NIH Device Record Key: dea32ea0-6cd8-4533-aca7-5d6eb9b9966b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAL A
• Version Model Number: RX4000
• Catalog Number: RX4000
• 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: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Once opened, Calibrator A is stable for 2 months on board the analyser
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273206098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024014

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2016-09-26

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