Medical device licence · 95617 · Class 2
METASYSTEMS "DNA FISH PROBE"
Yes: licensed in Canada
Licence status Issued (active); first licensed August 19, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95617
- Licence holder
- Metasystems Probes GmbhAltlussheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 19, 2015
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- METASYSTEMS CENTROMERE ENUMERATION PROBES
- METASYSTEMS LOCUS SPECIFIC PROBES
- METASYSTEMS TISSUEFISH PROBES
- XL ABL1 BA
- XL CRLF2 BA
- XL IGH/MAFB DF
- XL KMT2A BA
- XL P2RY8 DEL
- XL PDGFRA BA
- XL T(10;11) MLLT10/KMT2A DF
- XL T(11;19) KMT2A/MLLT1 DF
- XL T(14;18) IGH/MALT1 DF
- XL T(4;11) AFF1/KMT2A DF
- XL T(6;11) AFDN/KMT2A DF
- XL T(8;9) PCM1/JAK2 DF
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.