IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected supplier.
Product name BLOOD GROUPING TILE
Type of Immunoassay/ Intended Used:
Blood type identification
Description:
White acrylic of ceramic tile of plate for multiple blood samples, include columns for Anti-A, Anti-B, Anti-AB, Auto Control, A Cells, B Cells, O Cells, Rhesus Grouping for Anti-D, and Rhesus Grouping for Control.
Features:
Glazed surface.
Acid and alkali resistant
Easy to clean
Autoclavable
with 12 +- well depressions.
Reusable
Packaging/labelling
Primary packaging: Unit presentation: 1(one) Plate, cross matching/grouping, sets.
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. Batch number, Information for storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonized symbol) and Information for handling.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Classification:
Classified under EU MDR 2017/745 as Class II device
Environmental requirements:
Rohs compliance
ISO 14001 Material of batteries environmentally friendly
Not use of PVC
These technical specifications are generic and may vary depending on the selected supplier.
Product name BLOOD GROUPING TILE
Type of Immunoassay/ Intended Used:
Blood type identification
Description:
White acrylic of ceramic tile of plate for multiple blood samples, include columns for Anti-A, Anti-B, Anti-AB, Auto Control, A Cells, B Cells, O Cells, Rhesus Grouping for Anti-D, and Rhesus Grouping for Control.
Features:
Glazed surface.
Acid and alkali resistant
Easy to clean
Autoclavable
with 12 +- well depressions.
Reusable
Packaging/labelling
Primary packaging: Unit presentation: 1(one) Plate, cross matching/grouping, sets.
Note: Pack Sizes are not limited to the ones indicated above. It will be considered bigger of smaller ones according to the UNFPA Needs and products availability.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. Batch number, Information for storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonized symbol) and Information for handling.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Classification:
Classified under EU MDR 2017/745 as Class II device
Environmental requirements:
Rohs compliance
ISO 14001 Material of batteries environmentally friendly
Not use of PVC
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $19.10 |
