--

Trade name

not provided

06956013940342

B-06956013940342

Reference / catalog number

--

GS1

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

In vitro diagnostic test kit for qualitative detection of hemoglobinn in stool specimens. Single-use rapid test for professional in vitro diagnostic use in clinical laboratories and medical clinics, results for auxiliary clinical reference only, not for treatment.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160203FECAL OCCULT BLOOD - RT & POC

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

• 1. The test kit is for IVD (In Vitro Diagnostic) only. 2. We receomend that the rapid test kit be used within 1 hour after opening and even be used immediately after opening especially under temprature over 40℃ or high humidity. Use after freezing or out of shelf life is not allowed. 3. Because the test is for blood, any source of blood will give a positive test. Blood from another source, like hematuria, bleeding mouth, nose, hemorrhoids or menstrual period may interfere with the test. 4. The interval or very few amount of gastrointestinal hemorrhage may give a negative result. 5. Eat meat, animal innards, raw food or vegetable contains iron in 3 days may give a positive test. 6. Improper operation, too much or too few sample, or too long time may cause inaccurate results. 7. The test kit is for one time use, the waste should be treated as medical waste.

  OTHER