| Primary Device ID | 05055273210125 |
| NIH Device Record Key | 9bc9942c-0c6b-4d04-8bb7-69c42ff3f75d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) |
| Version Model Number | LIA5144 |
| Catalog Number | LIA5144 |
| 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 |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com | |
| Phone | +442894451070 |
| technical.services@randox.com |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -80 Degrees Celsius and -20 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055273210125 [Primary] |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-01 |
| Device Publish Date | 2025-03-24 |
| 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) | 2025-04-01The 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. |
| 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 |