Identity
- Trade Name
- Pathfinder FDA UDI
- Generic Name
- Chlamydia trachomatis antigen IVD, reagent FDA UDI
- Device Name
- Pathfinder Chlamydia trachomatis 2 Well Direct Specimen Control Slides FDA UDI
- Model / Reference
- 12000149 FDA UDI
- Description
- Pathfinder Chlamydia trachomatis 2 Well Direct Specimen Control Slides FDA UDI
Identifiers
- Catalog Number
- 12000149 FDA UDI
- Primary DI / UDI-DI
- 00847865012775 FDA UDI
- 510(k) Number
- K880031 FDA UDI
- FDA Product Code
- LJP FDA UDI
- GMDN Term
- Chlamydia trachomatis antigen IVD, reagent 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chlamydia trachomatis antigen IVD, reagent
Pathfinder by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chlamydia trachomatis antigen IVD, reagent.
- PathoDx Chlamydia trachomatis Direct Specimen — REMEL EUROPE LIMITED · Class I
- PathoDx Chlamydia Culture Confirmation — REMEL EUROPE LIMITED · Class I
- Pathfinder — Bio-Rad Laboratories · Class I
- Pathfinder — Bio-Rad Laboratories · Class I
- Pathfinder — Bio-Rad Laboratories · Class I
- Pathfinder — Bio-Rad Laboratories · Class I
Cleared under the same submission
K880031 also covers:
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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI df145d43-2047-45f3-bd25-d87e69ff3bf4 38 fields · synced May 30, 2026