RealAccurate® Quadruplex Mycobacteria PCR kit

Primary DI

08719326569963

Basic UDI-DI Code

B-08719326569963

Reference

PF0920-R

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PathoFinder B.V.

RealAccurate® Quadruplex Mycobacteria PCR Kit is a CE marked, qualitative, multiplex real-time PCR-based in vitro diagnostic product to detect and differentiate between MTBC species and clinically relevant NTM within 75 minutes. The input sample is total nucleic acid extracted and purified from sputum, bronchoalveolar lavage (BAL), sediments obtained after N-Acetyl-L-Cysteine (NALC) decontamination of sputum or BAL, and Mycobacteria Growth Indicator Tube (MGIT™) samples. RealAccurate® Quadruplex Mycobacteria PCR Kit is validated for use with NucliSENS® easyMAG® (bioMérieux), QIAamp® MinElute® Virus Spin Kit (QIAGEN) and RTP® Pathogen Kit (Stratec Molecular) for nucleic acid extraction from above-mentioned specimen types. RealAccurate® Quadruplex Mycobacteria PCR Kit is validated for use with real-time PCR instruments LightCycler® 480 II (Roche), Rotor-Gene® Q (QIAGEN), Mic qPCR Cycler (Bio Molecular Systems) and CFX96™ (Bio-Rad) for the detection of pathogen(s) nucleic acid.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).