LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) LIA5143

GUDID 05055273210118

The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH Vitamin D,17-OH-Progesterone, Alpha-fetoprotein (AFP), Aldosterone, Androstenedione, Beta-2-Microglobulin (B-2M), CA125, CA15-3, CA19-9, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-Sulphate, Digoxin, Ferritin, Folate, FSH, Gentamicin, Growth Hormone (GH), Total Beta hCG, Homocysteine, IGF-1, Immunoglobulin E (IgE), Insulin, Luteinizing Hormone, NT-Pro BNP, Oestradiol, Paracetamol, Phenobarbital, Phenytoin, Progesterone, Prolactin, PSA Free, PSA Total, Sex Hormone Binding Globulin (SHBG), Anti TPO, T Uptake, Free T3, Total T3, Free T4 Total T4, Testosterone, Theophylline, Tobramycin, Thyroglobulin, Thyroid Stimulating Hormone (TSH), Troponin I, Troponin T, Valproic Acid, Vancomycin and Vitamin B12. The device is unassayed without target values and is suitable for use on both Immunoassay and Clinical Chemistry analysers. Liquid Immunoassay Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

RANDOX LABORATORIES LIMITED

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: 05055273210118
• NIH Device Record Key: 458e50be-c179-4f70-bd33-9d0d17e77ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)
• Version Model Number: LIA5143
• Catalog Number: LIA5143
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +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

• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -20 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273210118 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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: 2025-04-01
• Device Publish Date: 2025-03-24

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): 2025-04-01The Liquid Immunoassay Control is intended for use with in vitro diagnostic assays for the quantitative determination of 25-OH Vitamin D,17-OH-Progesterone, Alpha-fetoprotein (AFP), Aldosterone, Androstenedione, Beta-2-Microglobulin (B-2M), CA125, CA15-3, CA19-9, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-Sulphate, Digoxin, Ferritin, Folate, FSH, Gentamicin, Growth Hormone (GH), Total Beta hCG, Homocysteine, IGF-1, Immunoglobulin E (IgE), Insulin, Luteinizing Hormone, NT-Pro BNP, Oestradiol, Paracetamol, Phenobarbital, Phenytoin, Progesterone, Prolactin, PSA Free, PSA Total, Sex Hormone Binding Globulin (SHBG), Anti TPO, T Uptake, Free T3, Total T3, Free T4 Total T4, Testosterone, Theophylline, Tobramycin, Thyroglobulin, Thyroid Stimulating Hormone (TSH), Troponin I, Troponin T, Valproic Acid, Vancomycin and Vitamin B12. The device is unassayed without target values and is suitable for use on both Immunoassay and Clinical Chemistry analysers. Liquid Immunoassay Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
• 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