| Primary Device ID | 05055273216493 |
| NIH Device Record Key | 68abc30b-1b32-4f2b-8082-95555b0053ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) |
| Version Model Number | SR10351 |
| Catalog Number | SR10351 |
| 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 | 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 |
| 05055273216493 - SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) | 2020-05-19Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum.
Serology Negative Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
Serology Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation. |
| 05055273216493 - SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) | 2020-05-19 Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detect |
| 05055273216509 - SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) | 2020-05-19 Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Vi |
| 05055273216516 - SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +) | 2020-05-19 Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Ant |
| 05055273216523 - SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) | 2020-05-19 Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core A |
| 05055273216462 - CO2/ELECTROLYTE LINEARITY VERIFIERS (For Roche Systems) (CO2 LIN VER) | 2020-05-15 CO2/Electrolyte Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Car |
| 05055273216448 - APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) | 2020-04-27 Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU |
| 05055273216455 - LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC) | 2020-04-27 Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL, |
| 05055273216479 - BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE) | 2020-04-27 Bilirubin Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Total and Dir |