IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
Disposable capillary tubes ( microcuvettes) used with Photometer HemoCue Hb 301 or equivalent. Very fine plastic tube provided with anticoagulant, designed to sample blood through capillarity. Used for determining haematocrit.
Materials: plastic microcuvette
Capacity: 8-10µl
Disposable
Anticoagulant: Heparin
Chemistry method: Determination of Hb and HbO2 at a single isobestic point using whole blood.
Stability: Unopened to be stored at 10-40°C (50-104°F) until expiry date printed on container
Short-term storage (6 weeks) -18-50°C (0.4-122°F).
stability once open : stable for three months.
Instructions for use:
For use with HemoCue Hb 301 analyzer or equivalent for measuring whole blood haemoglobin. Used for determining haematocrit. Blood sample is drawn into the cavity by capillary action. Sample of venous, or arterial blood may be used for testing
Should be stored at 10-40°C (50-104°F) until expiry date printed on container.
Once opened the microcuvettes are stable for three months.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packing: 50 microcuvettes tube-shaped container (vial), with screw cap.
Labelling on primary packaging:
-Name and/or trademark of the manufacturer.
-Manufacturer's product reference.
- Type of product and main characteristics (dimensions, capacity)
- Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol)
- Lot number prefixed by the word "LOT" (or equivalent harmonised symbol
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Symbols used according ISO 15223 an EN 980
CE mark
Secondary packaging:
4 container ( of 50 cuvettes each one ) in a box . Total of 200 microcuvettes in a box with manufacture´s instruction for use .
Labelling on secondary packaging:
-Name and/or trademark of the manufacturer.
-Manufacturer's product reference.
- Type of product and main characteristics (dimensions, capacity)
- Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol)
- Lot number prefixed by the word "LOT" (or equivalent harmonised symbol
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or
equivalent harmonised symbol).
Number of units/pieces
Symbols used according ISO 15223 an EN 980
CE mark
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
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 14820:2004 Single-use containers for human venous blood specimen collection.
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use .
ISO 12772:1997: Disposable microhaematocrit capillary tubes
Environmental requirements:
Not use PVC polymer
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
Disposable capillary tubes ( microcuvettes) used with Photometer HemoCue Hb 301 or equivalent. Very fine plastic tube provided with anticoagulant, designed to sample blood through capillarity. Used for determining haematocrit.
Materials: plastic microcuvette
Capacity: 8-10µl
Disposable
Anticoagulant: Heparin
Chemistry method: Determination of Hb and HbO2 at a single isobestic point using whole blood.
Stability: Unopened to be stored at 10-40°C (50-104°F) until expiry date printed on container
Short-term storage (6 weeks) -18-50°C (0.4-122°F).
stability once open : stable for three months.
Instructions for use:
For use with HemoCue Hb 301 analyzer or equivalent for measuring whole blood haemoglobin. Used for determining haematocrit. Blood sample is drawn into the cavity by capillary action. Sample of venous, or arterial blood may be used for testing
Should be stored at 10-40°C (50-104°F) until expiry date printed on container.
Once opened the microcuvettes are stable for three months.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packing: 50 microcuvettes tube-shaped container (vial), with screw cap.
Labelling on primary packaging:
-Name and/or trademark of the manufacturer.
-Manufacturer's product reference.
- Type of product and main characteristics (dimensions, capacity)
- Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol)
- Lot number prefixed by the word "LOT" (or equivalent harmonised symbol
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Symbols used according ISO 15223 an EN 980
CE mark
Secondary packaging:
4 container ( of 50 cuvettes each one ) in a box . Total of 200 microcuvettes in a box with manufacture´s instruction for use .
Labelling on secondary packaging:
-Name and/or trademark of the manufacturer.
-Manufacturer's product reference.
- Type of product and main characteristics (dimensions, capacity)
- Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol)
- Lot number prefixed by the word "LOT" (or equivalent harmonised symbol
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or
equivalent harmonised symbol).
Number of units/pieces
Symbols used according ISO 15223 an EN 980
CE mark
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
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 14820:2004 Single-use containers for human venous blood specimen collection.
ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use .
ISO 12772:1997: Disposable microhaematocrit capillary tubes
Environmental requirements:
Not use PVC polymer
| Pack Size | Avg. Price |
|---|---|
| Pack of 200 | $121.54 |
