Medical Device Division · registration 110411ExpiredHologic
Hong KongIVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, ReplicationIVD Class DHologic, Inc.
Official record identity
- MDACS listing number
- 110411
- Model name
- Procleix Ultrio Assay (1000-Test Kit) (301103), Procleix Ultrio Assay (5000-Test Kit) (301105), Procleix Ultrio Assay Calibrators (301106), Procleix Ultrio HBV Discriminatory Probe (301109), Procleix Ultrio HCV Discriminatory Probe (301108), Procleix Ultrio HIV-1 Discriminatory Probe (301107), Procleix Ultrio Tigris Controls (302193), Procleix Ultrio Negative Calibrator Kit (303259), Procleix Ultrio Tigris Negative Controls Kit (303258), Procleix Auto Detect Reagents Kit (301120), Procleix Oil Kit (302441), Procleix Wash Solution (303665), Procleix Buffer for Deactivation Fluid (303666)
- Registration date
- August 05, 2015
- Expiry date
- November 18, 2016
- Source update date
- January 01, 2000
- Status
- Expired
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication
Official value: D
Published parties
- Registrant / registration holder
- Grifols (HK) Limited
- Manufacturer
- Hologic, Inc.
Official description
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
Additional source fields
- AMD nomenclature code
- 19666
- Local responsible person phone
- 21613100
- Published manufacturer address
- 10210 Genetic Center Drive, San Diego, CA 92121, United States
- Published remarks
- Expired.
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.