Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
π¨π³ China
CHLAMYDIA AG - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180728001NE
- Basic UDI-DI Code
- B-CNM0000180728001NE
- Reference
- 8001C
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
The Chlamydia Rapid Test is a rapid, lateral flow immunoassay intended for the qualitative detection of Chlamydia trachomatis directly from a female endocervical swab or male urethral swab, in addition to male urine specimens from symptomatic patients. The test is intended for professional and in vitro diagnostic use as an aid in the diagnosis of Chlamydia infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090101 | CHLAMYDIA AG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 076482 0004 | TΓV SΓD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market