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Product dimensions: 78 x 43 x 3 mm

Sample disc diameter: 6mm

Sample volume: 2 x 10 µl

DBS paper: Ahlstrom grade 222
>80% of the device is paper based
<1,2 grams of plastics per device

Reproducibility:
Better than 0.5 μl as one Standard
Deviation (SD), (CV <5%)

Outliers:
Rate of over- or under-sampling
(with a deviation >3 SD) <0.1%
Non-sampling: <5%

Temperature range: +15°C to +35°C
Relative humidity range: 15% to 90%
Hematocrit value: 25% to 55%

The card must be used within 30 minutes from opening the package

Collected qDBS samples can be stored at room temperature.

The stability of individual analytes in DBS samples should be validated by the responsible laboratory. In general, stability increases with lower temperature and lower humidity. qDBS discs can be stored in the freezer to extend stability. Please refer to the extensive literature for traditional DBS samples as guidance for individual analytes.

Dispose according to local regulations. Take care with blood stained materials and sharps.

Capitainer®B is CE-marked, registered as an IVD product according to the IVD Regulation (EU) 2017/746 and registered with the US FDA as a Device Class 1.

CAPITAINER AB
Solna Torg 19
SE-171 45 Solna
SWEDEN

Product dimensions: 78 x 43 x 4 mm

Sample disc diameter: 6 mm

Sample volume: 2 x 50 +/- 0,98 µl

DBS paper: Ahlstrom grade 320

Reproducibility:
Standard deviation less than 0.98 μl (CV < 2%).

Outliers:

Probability of overfilling or underfilling (deviation> 3 SD) < 1%**.

Risk of no sample: < 1%**.

**Success run testing with safety delay: ∆T>6seconds, 35 and 45% Hematocrit,
Reliability 99%, Confidence 95%, n=300, 0 failures accepted.

Temperature range: +15°C to +35°C
Relative humidity range: 15% to 90%
Hematocrit value: 25% to 55%

The card must be used within 30 minutes from opening the package

Collected qDBS samples can be stored at room temperature.

The stability of individual analytes in DBS samples should be validated by the responsible laboratory. In general, stability increases with lower temperature and lower humidity. qDBS discs can be stored in the freezer to extend stability. Please refer to the extensive literature for traditional DBS samples as guidance for individual analytes.

Dispose according to local regulations. Take care with blood stained materials and sharps.

Capitainer®B 50 is CE-marked, registered as an IVD product according to the IVD Regulation (EU) 2017/746 and registered with the US FDA as a Device Class 1.

CAPITAINER AB
Solna Torg 19
SE-171 45 Solna
SWEDEN