PRINCIP
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.
produktnavn | One Step HCG Urine Pregnancy Test |
Mærke navn | GOLDEN TIME, OEM-Buyer’s logo |
Doseringsform | In vitro diagnostisk medicinsk udstyr |
Metodik | Kolloidt guld immun kromatografisk assay |
Prøve | Urin |
Format | Strip |
materiale | Paper + PVC |
Specifikation | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
Følsomhed | 25mIU/ml eller 10mIU/ml |
Pakning | 1/2/5/7/20/25/40/50/100 test/kasse |
Nøjagtighed | >=99,99 % |
Specificitet | Ingen tværgående reaktivitet med 500mIU/ml hLH, 1000mIU/ml hFSH og 1mIU/ml hTSH |
Reaktionstid | 1-5 minutter |
Læsetid | 3-5 minutter |
Holdbarhed | 36 måneder |
anvendelsesområde | Alle niveauer af medicinske enheder og hjemme-selvtest. |
Certificering | CE, ISO, NMPA, FSC |
REAGENSER
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
LEVERET MATERIALER
Hver pose indeholder:
1.One One Step HCG Pregnancy Test strip
2. Tørremiddel
Hver kasse indeholder:
1.One One Step HCG Pregnancy Test foil pouch
2.Urinkop
3. Indlægsseddel
Der er ikke behov for andet udstyr eller reagenser.
OPBEVARING OG STABILITET
Store test strip at 4~ 30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.