Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Mycoplasma pneumoniae and Macrolides-resistant strain nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06970895475570
Basic UDI-DI Code
B-06970895475570
Reference
R061T016B0C1
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is intended to detect of Mycoplasma pneumoniae and Macrolides-resistant (MR) mutation sites of 23S rRNA 2063 (A>G) and 2064 (A>G) in sputum samples qualitatively. For professional in-vitro diagnostic use.

CND Nomenclature Codes

Code Description
W0105010118 CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS

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