Identity
- Trade Name
- PathoDx Chlamydia trachomatis Control Slide FDA UDI
- Generic Name
- Chlamydia trachomatis antigen IVD, control FDA UDI
- Model / Reference
- R62205 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501901 FDA UDI
- FDA Product Code
- LJP FDA UDI
- GMDN Term
- Chlamydia trachomatis antigen IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chlamydia trachomatis antigen IVD, control
PathoDx Chlamydia trachomatis Control Slide by Remel Europe Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Remel Europe Limited
Sources (1)
- FDA UDI 9f146b5f-592f-450b-b04f-f3262249dc1d 33 fields · synced May 29, 2026