Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
Chlamydia pneumoniae IgA EIA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06438172124011
- Basic UDI-DI Code
- B-06438172124011
- Reference
- 6111310
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Chlamydia pneumoniae IgA test is developed for the detection of IgA antibodies specific to Chlamydia pneumoniae in human serum or plasma. The kit is semiquantitative allowing comparison of paired samples. The change of antibody level is an aid for the diagnosis of acute Chlamydia pneumonia infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010114 | CHLAMYDIA PNEUMONIAE ANTIBODY IGA |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1172-794-22 | Eurofins Electric & Electronics Finland Oy | Expired |
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