Medical Device Division · registration 150294ExpiredHologic
Hong KongIVD Test Reagent/Kits, Molecular Assay, Nucleic Acid ProbeIVD Class DHologic, Inc.
Official record identity
- MDACS listing number
- 150294
- Model name
- Procleix Ultrio Elite Assay (303330, 303715), Procleix Ultrio Elite HIV, HCV and HBV Discriminatory Probe Reagents (303334), Procleix Ultrio Elite Target Enhancer Reagent (303331, 303722), Procleix Ultrio Elite Negative Calibrators (303333), Procleix Ultrio Elite Positive Calibrators (303332), Procieix Ultrio Elite Assay Calibrators Kit (303719, 303723), Procleix Assay Fluids Kit (303344), Procleix Auto Detect Reagents Kit (303345)
- Registration date
- September 24, 2015
- Expiry date
- September 24, 2020
- Source update date
- January 01, 2000
- 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.
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.