ARE THE PRODUCTS APPROVED?
All of the tests supplied by 1st Health Products Ltd under the SELFCheck brand comply with the current CE/IVD EU directives applied to In-vitro diagnostic devices for home use and the company has ISO 13485:2003 accreditation.
SHELFLIFE and STORAGE?
The products are supplied with the maximum shelf life, typically 15 months or more.
The products do not require refrigeration: they should be stored in ambient temperatures and out of direct sunlight and away from central heating radiators.
All of our tests are individually labelled detailing the expiry date and lot/batch number so that batch traceability can be maintained. The outer boxes have tamper evident closures at both ends to prevent pilfering/theft.
DO I NEED ANY INSTRUMENTATION TO CARRY OUT THE TEST?
All of our screening tests are supplied with all of the peripheral items that are needed to carry out the tests safely and reliably. The only additional items needed are a timing device with a minute hand and a suitable urine sample collection container.
The contents for each test are listed on the outside of the packaging and include items such as single use lancets, alcohol wipe, buffer vials and test device, together with comprehensive Instructions For Use leaflets.
HOW ACCURATE ARE THE TESTS?
The core technology employed is the same technology as that used in the pathology labs and is as accurate as a lab result. Part of the CE/IVD approval process requires the manufacturer to product trial data as part of the verification/validation.
CAN THE TESTS BE USED MORE THAN ONCE?
The test strips are designed for single use only even if the test is negative. Where a lancet device is provided it is also a single use lancet.
WHAT SHOULD I DO IF THE RESULT IS POSITIVE?
Consult your own GP so that further investigations and examinations can be carried out.
THE TEST RESULT WAS NEGATIVE BUT I STILL HAVE SYMPTOMS?
If the test proves negative but symptoms or concerns persist consult your GP as soon as possible.
MOST FREQUENT CONSUMER ISSUES:
My result is not clear?
The test result should mirror the pictorial illustrations found in the Instructions for Use leaflet. If this is not the case please call our Customer Careline for assistance.