Medical device licence · 99323 · Class 2
ANALYTE SPECIFIC REAGENTS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 20, 2017; ended October 25, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 99323
- Licence holder
- Hologic, Inc.Sunnyvale, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- June 20, 2017
- Ended
- October 25, 2022
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CANDIDA GLABRATA AMPLIFICATION NON-T7 OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA GLABRATA PROMOTER OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA GLABRATA TARGET CAPTURE OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA PARAPSILOSIS AMPLIFICATION NON-T7 OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA SPECIES AMPLIFICATION NON-T7 OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA SPECIES PROMOTER OLIGO ANALYTE SPECIFIC REAGENT
- CANDIDA SPECIES TARGET CAPTURE OLIGO ANALYTE SPECIFIC REAGENT
- GARDNERELLA VAGINALIS AMPLIFICATION NON-T7 OLIGO ANALYTE SPECIFIC REAGENT
- GARDNERELLA VAGINALIS PROMOTER OLIGO ANALYTE SPECIFIC REAGENT
- GARDNERELLA VAGINALLIS TARGET CAPTURE OLIGO ANALYTE SPECIFIC REAGENT
- LACTOBACILLUS GASSERI PROMOTER OLIGO ANALYTE SPECIFIC REAGENT
- LACTOBACILLUS SPECIES AMPLIFICATION NON-T7 OLIGO ANALYTE SPECIFIC REAGENT
- LACTOBACILLUS SPECIES PROMOTER OLIGO ANALYTE SPECIFIC REAGENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.