← Back to catalogue

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 Monoclonal Antibody FDA UDI
Model / Reference
30702 FDA UDI
Description
Pathfinder Chlamydia trachomatis Direct Specimen Monoclonal Antibody FDA UDI

Identifiers

Catalog Number
30702 FDA UDI
Primary DI / UDI-DI
00847865001441 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

Dimensions & Sizes

Size
Total Volume — 4.2 Milliliter 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.

Cleared under the same submission

K880031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI 9e65329a-b744-4f2b-8bdc-76f11bf12404 38 fields · synced May 30, 2026