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Pathfinder

FDA UDI

Class I (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Pathfinder FDA UDI
Generic Name
Chlamydia trachomatis antigen IVD, reagent FDA UDI
Device Name
Pathfinder Chlamydia trachomatis Direct Specimen System FDA UDI
Model / Reference
30704 FDA UDI
Description
Pathfinder Chlamydia trachomatis Direct Specimen System FDA UDI

Identifiers

Catalog Number
30704 FDA UDI
Primary DI / UDI-DI
00847865001434 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

Yes

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

A comprehensive medical device for direct specimen collection and testing of Chlamydia trachomatis bacteria.

Similar devices

Also classified as Chlamydia trachomatis antigen IVD, reagent.

Cleared under the same submission

K880031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI a0f84a31-f752-48ea-a9fa-7c0c48cd5a38 38 fields · synced Jul 12, 2026