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.
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