Blood grouping ABO&Rhd Dry type, Kit/50T

General description:
Blood grouping, ABO and RhD Dry type test, 50 Tests/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.

Manufacturer product reference:
Eldon Biologicals 610-11.

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

Items supplied with:
·1 Eldon Bag 2521-25 containing 25 double cards (a total of 50 blood type determinations) in a moisture-proof aluminium/plastic bag containing 1 desiccant sachet.
·200 x EldonSticks (stirring pins).
·50 x Safety Lancets. CE Certificate (HTL Strefa S.A Poland)
·50 x Alcohol swabs. (Manufacturer Vitrex Medical A/S Denmar‫ (‬
·25 x ELDONFOIL 2521. (Covers two 2521 cards)
·2 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.

Shelf life:
24 Months.

Weight & volume:
Estimated Weight: 0.314Kg.
Estimated Volume: 0.0027m3.

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, 50T/KIT.