原則
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.
| 產品名稱 | One Step HCG Urine Pregnancy Test |
| 品牌 | GOLDEN TIME, OEM-Buyer’s logo |
| 劑型 | 體外診斷醫療器械 |
| 方法 | 膠體金免疫層析法 |
| 標本 | 尿 |
| 格式 | 卡帶 |
| 材料 | 防抱死制動系統 |
| 規格 | 2.5mm 3.0mm 4.0mm 5.0mm |
| 包裝 | 1/2/5/7/20/25/40/50/100 測試/盒 |
| 靈敏度 | 25mIU/ml 或 10mIU/ml |
| 準確性 | >=99.99% |
| 特異性 | 與 500mIU/ml 的 hLH、1000mIU/ml 的 hFSH 和 1mIU/ml 的 hTSH 無交叉反應 |
| 反應時間 | 1-5分鐘 |
| 閱讀時間 | 3-5分鐘 |
| 保質期 | 36個月 |
| 適用範圍 | 各級醫療單位及家庭自檢。 |
| 認證 | CE、ISO、NMPA、FSC |
試劑
每個鋁箔袋進行一次 HCG 妊娠試驗。
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
提供的材料
每個小袋包含：
1.One One Step HCG Pregnancy Test cassette
2.乾燥劑
3.滴管
每個盒子包含：
1.One One Step HCG Pregnancy Test foil pouch
2.尿杯
3.包裝插頁
不需要其他設備或試劑。
儲存和穩定性
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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