Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
Chlamydia Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- 06970277511032
- Basic UDI-DI Code
- B-06970277511032
- Reference
- ICH-502
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The Chlamydia Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in female cervical swab, male urethral swab or male urine specimens to aid in the diagnosis of Chlamydia infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010107 | CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1095123 0008 | TÜV SÜD Product Service GmbH | Expired |
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