Medical Device Division · registration 110240ExpiredHologic
Hong KongIVD Test Reagent/Kits, Molecular Assay, Nucleic Acid ProbeIVD Class DHologic, Inc.
Official record identity
- MDACS listing number
- 110240
- Model name
- Procleix Ultrio Plus Assay (302573, 302574, 302575, 302576, 302577, 302571, 302572, 30260, 30261, 303665, 302441, 303666, 301120, 301175)
- Registration date
- August 23, 2016
- Expiry date
- August 23, 2021
- Source update date
- June 21, 2016
- Status
- Expired
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
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
- b
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.