BEGINSEL
The One Step HCG Pregnancy Test is a rapid qualitative one step assay for the detection of HCG in urine. The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, level of HCG as low as 25mlU/ml can be detected.
| productnaam | One Step HCG Urine Pregnancy Test |
| Merknaam | GOLDEN TIME, OEM-Buyer’s logo |
| Doseringsvorm | Medisch hulpmiddel voor in-vitrodiagnostiek |
| Methodologie | Colloïdaal goud immuunchromatografische test |
| Exemplaar | Urine |
| Formaat | Strip |
| materiaal | Paper + PVC |
| Specificatie | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| Gevoeligheid | 25mIU/ml of 10mIU/ml |
| Inpakken | 1/2/5/7/20/25/40/50/100 testen/doos |
| Nauwkeurigheid | >=99,99% |
| Specificiteit | Geen cross-reactiviteit met 500mIU/ml hLH, 1000mIU/ml hFSH en 1mIU/ml hTSH |
| Reactietijd | 1-5 minuten |
| Leestijd | 3-5 minuten |
| Houdbaarheid | 36 maanden |
| toepassingsmogelijkheden | Alle niveaus van medische eenheden en zelftest thuis. |
| Certificering | CE, ISO, NMPA, FSC |
REAGENTIA
One HCG pregnancy test strip per foil pouch.
Ingredients: Test device comprised colloidal gold coated with anti β-hCG antibody,
nitrocellulose membrane pre-coated goat anti mouse IgG and mouse anti α -HCG
MATERIALEN GELEVERD
Elk zakje bevat:
1.One One Step HCG Pregnancy Test strip
2. Droogmiddel
Elke doos bevat:
1.One One Step HCG Pregnancy Test foil pouch
2. Urinebeker
3. Bijsluiter
Er zijn geen andere apparatuur of reagentia nodig.
OPSLAG EN STABILITEIT
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.
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