Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent
Taiwan·Risk Class 3·Hologic LTD;; Hologic, Inc.·Registered May 30, 2024 – May 30, 2029Active- Analysis ID
- c5b1537cb033ffc880f24f71681b6d53
- Customs Code
- DHA05603708300
- Manufacturer
- Hologic LTD;; Hologic, Inc.
- Manufacturer Country
- United Kingdom;;United States
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
- Intended Use
- This product is a nucleic acid amplification assay 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 to assist in the clinical management of patients with HIV-1 infection. This product is not intended for HIV screening in blood or plasma donors.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- Input;; QMS/QSD
- Registration Date
- May 30, 2024
- Expiry Date
- May 30, 2029
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Access comprehensive regulatory information for Horopeg Human Immunodeficiency Virus Type 1 Virality Nucleic Acid Detection Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number c5b1537cb033ffc880f24f71681b6d53 and manufactured by Hologic LTD;; Hologic, Inc.. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
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