Eu Ivdr Eu Ivd Class C On The Market 🇮🇹 Italy

CHORUS MYCOPLASMA PNEUMONIAE IgG

DIESSE Diagnostica Senese S.p.A · 🇮🇹 Italy
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
08033891322250
Basic UDI-DI Code
803389132CHORUSMYG00C4
Reference
81034
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class C
Status
On The Market

Additional Description

"CHORUS Mycoplasma pneumoniae IgG (REF 81034) is an immunoassay kit for the automated semi-quantitative determination of IgG antibodies against Mycoplasma pneumoniae. Mycoplasma Pneumoniae is the most common etiological agent causing pneumonia acquired in community environments. The IgG appear after the IgM and IgA and they generally reach the peak level during the 5° week, therefore the kit is used as an aid in the diagnosis of pneumonia infection. The test, performed in human serum using a disposable device applied to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory personnel only. "

CND Nomenclature Codes

Code Description
W0105010802 MYCOPLASMA ANTIBODY ASSAYS

Available In Countries

🇮🇹 Italy

Similar Devices

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).

View all