MeningoFinder® 2SMART

Primary DI

08719327116111

Basic UDI-DI Code

B-08719327116111

Reference

PF1200-2S

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

PathoFinder B.V.

The MeningoFinder® 2SMART (Single tube Multiplex Amplification in Real Time) kit is non-automated qualitative multiplex PCR-based test to aid in the diagnosis of meningitis or encephalitis in humans by detecting and differentiating 4 RNA viruses, 8 DNA viruses, 8 species/groups of bacteria and 2 species of fungi: mumps virus, measles virus, human enteroviruses (EV), parechoviruses, herpes simplex virus (HSV) type 1, herpes simplex virus type 2, varicella zoster virus, Epstein–Barr virus, cytomegalovirus, human herpesvirus 6 (HHV-6), HHV-7, HHV-8, Listeria monocytogenes, Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus agalactiae, Neisseria meningitidis, Borrelia burgdorferi sensu lato (s.l.) (B. burgdorferi sensu stricto (s.s.), B. afzelii, B. garinii, B. spielmanii, B. bavariensis and B. valaisiana) / B. miyamotoi (not distinguished) [3], Escherichia coli K1, Cryptococcus neoformans s.l. (C. neoformans serotypes A and D: C. neoformans var. neoformans, C. neoformans var. grubii and Filobasidiella neoformans) and Cryptococcus gattii s.l. (C. neoformans serotypes B and C: C. gattii, C. neoformans var Bacillisporus and Filobasidiella neoformans var bacillispora) [4]. The MeningoFinder® 2SMART is for use with LightCycler® 480 / cobas® z480 (Roche), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific).

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).