Blood grouping ABO&RhD Dry type, Kit/1T

General description:
Blood grouping, ABO and RhD Dry type Kit, One Man Kit.

Intended Use
Blood grouping, ABO/RhD Dry type kit is intended for in-vitro detection and identification of A, B and RhD antigens on human red blood cells by direct agglutination. It’s intended for professional use in the field, where cold-chain facilities are not available, or at clinics and hospitals choosing to use dry format cards.

Technical specifications:
·Test principle: Forward haemagglutination by dried antibody reagents.
·Dried antibody reagents on card. Anti-A field contains murine IgM monoclonal (Titre 1:32), Anti-B field contains murine IgM monoclonal (Titre 1:32), Anti-D field contains human monoclonal IgM (Titre 1:32).
·Sample type: Capillary Blood or Venous blood stabilised with either anticoagulant CPD or EDTA.
·Sensitivity: 100%
·Specificity: 100%
·Does not require cold-chain storage/shipping.
·Individually packed.

Manufacturer product reference:
Eldon Biologicals 500-08.

QMS/Regulatory information:
ISO 13845:2016.
CE-IVD

Items supplied with:
·1 x EldonCard 2511 (in envelope)
·4 x EldonSticks (stirring pins).
·2 x Safety Lancets. CE Certificate (HTL Strefa S.A Poland)
·1 x Alcohol swabs. (Manufacturer Vitrex Medical A/S Denmark)
·1 x ELDONFOIL 2521.
·1 x Plastic Droppers.
·1 x Instruction for Use (IFU).

Items required, but not supplied:
·Antibody diluent/water vial. Can be separately ordered if needed using material U484997 for settings with no accesses to water vials or potable water.
·A clock or timer.
·A clock or timer.

Shelf life:
24 Months.

Weight & volume:
Estimated Weight: 0.0268Kg.
Estimated Volume: 0.000192m3.

Storage & transportation condition:
5 to 37 ºC. Keep away from rain and store in dry condition.

Packaging & labelling:
Primary packaging: Blood grouping ABO and RhD Dry type test.
All contents of Blood grouping, ABO and RhD Dry type kit, one man kit 1T/KIT.