Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent
Taiwan·Risk Class 3·Hologic, Inc.·Registered May 04, 2023 – May 04, 2028Active- Analysis ID
- 4a0e00ae5dd0df352fd8c7e75f682f8d
- Customs Code
- DHA05603616902
- Manufacturer
- Hologic, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
- Intended Use
- This product is a nucleic acid amplification detection reagent for in vitro diagnostics for the detection and quantification of human immunodeficiency virus type 1 (HIV-1) RNA groups M, N and O on a fully automated Panther system. This product is used to assist in the diagnosis of HIV-1 infection and in the clinical management of HIV-1 infected patients. This product is not intended for HIV screening for blood or plasma donations.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 輸入
- Registration Date
- May 04, 2023
- Expiry Date
- May 04, 2028
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