IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
A ceramic tile used to control for blood group type; blood and a blood group reagent are mixed in the holes.
Material: pure white porcelain.
Glazed surface.
Acid and alkali resistant
Easy to clean
Autoclavable
with 12 well depressions.
Size wells: approximately 20 mm(diameter)
Reusable
Instructions for use:
Used to control for blood group type
Tile procelain must be cleaned and disinfecteed after use.
Supplied with:
Manufacturer's instruction for use ( English, French and Spanish).
Packaging and labelling:
Individually packaged in a transparent plastic bag with instruction for use
Product name, size, reference number, manufacturer's name and address, CE mark
The words “Non-sterile, reusable" (or equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223 and EN 980
Regulation & conformity requirements:
MDD) 98/79EEC
CE self-declaration
ISO 13485 certificate
Classification:
In Vitro Device( other than specified in List A or List B, Annex II ,IVD 98/79/EEC)
Safety & product Standards:
Must comply with following standards
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use.
Environmental requirements:
Not use PVC polymer
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
A ceramic tile used to control for blood group type; blood and a blood group reagent are mixed in the holes.
Material: pure white porcelain.
Glazed surface.
Acid and alkali resistant
Easy to clean
Autoclavable
with 12 well depressions.
Size wells: approximately 20 mm(diameter)
Reusable
Instructions for use:
Used to control for blood group type
Tile procelain must be cleaned and disinfecteed after use.
Supplied with:
Manufacturer's instruction for use ( English, French and Spanish).
Packaging and labelling:
Individually packaged in a transparent plastic bag with instruction for use
Product name, size, reference number, manufacturer's name and address, CE mark
The words “Non-sterile, reusable" (or equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223 and EN 980
Regulation & conformity requirements:
MDD) 98/79EEC
CE self-declaration
ISO 13485 certificate
Classification:
In Vitro Device( other than specified in List A or List B, Annex II ,IVD 98/79/EEC)
Safety & product Standards:
Must comply with following standards
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 14971:2007 Medical Devices- Application of risk management to medical devices
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use.
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $19.10 |
