The VARIANT II Hemoglobin A1c Program Reorder Pack is a fully automated assay using HPLC technology to deliver precise and accurate HbA1c results. The kit offers many enhanced attributes such as the ability to report HbA1c in the presence of HbS, HbC, HbD, and HbE traits. HbA1c results are also reportable in the presence of carbamylated Hb and labile A1c. The interchangeability of buffers within a column resin lot simplifies workflow and an extended kit shelf life provides streamlined inventory management.The VARIANT II Hemoglobin A1c Program Reorder Pack is NGSP-certified, correlates to the Diabetes Control and Complications Trial DCCT reference study, is CE marked to meet the European IVD Directive and traceable to the IFCC Reference Method.The VARIANT II -Thalassemia Short Program Reorder Pack offers fully automated, multi-analyte -thalassemia testing for increased laboratory productivity and accuracy. Each 6.5-minute assay provides simultaneous, quantitative results for percent.
Other Specifications Download Specification | |
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Conformity To Indian Standard | IS:9824(Part-3) Latest |
ISI Marked | Yes |
CM/L No | NA |
Type Of IV Set | Transfusion Set for Single Use (Designation : Transfusion Set IS 9824-3 TS) |
Transfusion/Infusion Set Provided With Injection Site | Yes |
Provision Of Closure Of Air Inlet With Vented Infusion Set | Yes |
Air Inlet Device With Air Filter Required | Yes |
Luer Lock Fitting | Yes |
I V Set Comply With The Provisions Of Drugs And Cosmatic Act 1940 As Amended Till Date | Yes |
Good Manufacturing Practices (GMP) Issued Under Revised Schedule -M Of Drugs And Cosmetics Act 1940 As Amended Or WHO-Good Manufacturing Practices (GMP)(For Manufacturers Only) | Yes |
Good Manufacturing Practices (GMP) Certificate No. | NA |
Good Manufacturing Practices (GMP) Certificate Date | NA |
Non Conviction Certificate Issued By The Concerned Drugs Control Authorities/ Licencing Authorities | Yes |
Non Conviction Certificate No. | NA |
Non Conviction Certificate Date | NA |
Availability Of Test Reports From Drug Controller Approved Laboratories Which Are Also Satisfying Central Govt./State Govt/NABL/IL AC Accredited Lab Covering All The Declared Parameters As Per IS Specification | Yes |
Test Report No | NA |
Test Report Date | NA |
Name Of The Lab | NA |
Address Of The Lab | NA |