Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
Chlamydia pneumoniae IgM EIA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- 06438172125018
- Basic UDI-DI Code
- B-06438172125018
- Reference
- 6111320
- 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 IgM test is developed for the detection of IgM antibodies specific to Chlamydia pneumoniae in human serum or plasma. The positive result is an aid for the diagnosis of acute Chlamydia pneumonia infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010116 | CHLAMYDIA PNEUMONIAE ANTIBODY IGM |
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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