04015600775100

Organization name

SPD Swiss Precision Diagnostics GmbH

SRN

CH-MF-000025175

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  For in vitro diagnostic use only. Not for internal use. Do not reuse test sticks. Keep out of reach of children. Store between 2° – 30°C. Allow to reach room temperature for 30 minutes prior to testing if stored refrigerated. Do not use if the foil wrapper is damaged. Do not use after the ‘use by’ date. Once test stick foil is opened, use immediately. This product contains batteries. Contains small parts. Do not eat any component of this device. If accidentally swallowed, seek medical attention. Report any injury caused by the use of this product to Clearblue and the competent authority of the member state. Only use test sticks for Clearblue Advanced Digital Ovulation Test with the holder. Not for contraceptive use. Results must be read on the display and not by any lines you might see on the test stick. Do not take apart, recharge, or dispose of the batteries in fire. Do not swallow. Keep away from children. Do not dispose of electrical equipment in fire. Clomiphene citrate does not affect the tests, but may affect the length of your cycle and, therefore, when you should be testing. You may need to continue testing with a new pack. You may get misleading results if you are pregnant, have recently been pregnant, have reached the menopause, have impaired liver or kidney function, have polycystic ovarian syndrome (PCOS). Always read the manufacturer’s instructions for any medication you are taking before testing. You may get misleading results if you are taking fertility drugs containing luteinising hormone (LH) or human Chorionic Gonadotrophin, or are taking antibiotics containing tetracyclines. Clomiphene citrate does not affect the tests. If you have recently stopped using hormonal contraception your cycles may be irregular so you may wish to wait until you have had 2 cycles before testing.

Primary placement in Sweden; available across 2 countries total.

Trade name

not provided

UDI-DI code

04015600775100

Basic UDI-DI

B-04015600775100

Reference / catalog number

04015600775100

Issuing entity

GS1

Risk category

IVDD — Self-testing

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

CLEARBLUE OVUL DHI 10CT SE/FI

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102160304LH - RT & POC

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification