PRINCIPIO
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.
| Nome do produto | One Step HCG Urine Pregnancy Test |
| Marca | GOLDEN TIME, OEM-Buyer’s logo |
| Forma de dosificación | Dispositivo Médico Diagnóstico In Vitro |
| Metodoloxía | Ensaio cromatográfico inmune de ouro coloidal |
| Exemplar | ouriños |
| Formato | Tira |
| material | Paper + PVC |
| Especificación | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| Sensibilidade | 25 mIU/ml ou 10 mIU/ml |
| Embalaxe | 1/2/5/7/20/25/40/50/100 probas/caixa |
| Precisión | >=99,99 % |
| Especificidade | Sen reactividade transversal con 500 mIU/ml de hLH, 1000 mIU/ml de hFSH e 1 mIU/ml de hTSH |
| Tempo de reacción | 1-5 minutos |
| Hora de Ler | 3-5 minutos |
| Vida útil | 36 meses |
| rango de aplicación | Todos os niveis de unidades médicas e autotest domiciliario. |
| Certificado | CE, ISO, NMPA, FSC |
REACTIVOS
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
MATERIAIS PROPORCIONADOS
Cada bolsa contén:
1.One One Step HCG Pregnancy Test strip
2.Desecante
Cada caixa contén:
1.One One Step HCG Pregnancy Test foil pouch
2.Conca de ouriños
3.Inserción do paquete
Non se necesitan outros equipos ou reactivos.
ALMACENAMENTO E ESTABILIDADE
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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