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FebriDx® Bacterial / Non-Bacterial Point of Care Assay

FDA UDI

Class II (US FDA UDI)

by Lumos Diagnostics, Inc.

Identity

Trade Name
FebriDx® Bacterial / Non-Bacterial Point of Care Assay FDA UDI
Generic Name
Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical FDA UDI
Device Name
FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests FDA UDI
Model / Reference
CP0014 FDA UDI
Description
FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests FDA UDI

Identifiers

Catalog Number
CP0014 FDA UDI
Primary DI / UDI-DI
00850056728102 FDA UDI
510(k) Number
K230917 FDA UDI
FDA Product Code
QXA FDA UDI
GMDN Term
Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3230 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical

FebriDx® Bacterial / Non-Bacterial Point of Care Assay by Lumos Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumos Diagnostics, Inc.

Sources (1)

  • FDA UDI a1ea6133-1542-42e8-814b-0d212c696245 37 fields · synced May 30, 2026