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

CHORUS MYCOPLASMA PNEUMONIAE IgA

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

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Basic Information

Primary DI
08033891327552
Basic UDI-DI Code
803389132CHORUSMYA00B6
Reference
81033
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class C
Status
On The Market

Additional Description

"CHORUS Mycoplasma pneumoniae IgA (REF 81033) is an immunoassay kit for the automated semi-quantitative determination of IgA antibodies against Mycoplasma pneumoniae. Mycoplasma Pneumoniae is the most common etiological agent causing pneumonia acquired in community environments. The IgA represent the highest sensitivity marker in case of an infection in progress, a reinfection, or a recent infection; 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. The device is For In Vitro Diagnostic Use Only. "

CND Nomenclature Codes

Code Description
W0105010802 MYCOPLASMA ANTIBODY ASSAYS

Available In Countries

🇮🇹 Italy

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