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Procise IFX

FDA UDI

Class II (US FDA UDI)

by Chembio Diagnostic Systems

Identity

Trade Name
Procise IFX FDA UDI
Generic Name
TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory. FDA UDI
Model / Reference
5385 FDA UDI
Description
The Procise IFX assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of infliximab levels in venous serum in patients undergoing infliximab therapy, using the ProciseDx Analyzer. Measurements obtained by this assay can be used to detect infliximab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with infliximab. The test is intended for use in a clinical laboratory. FDA UDI

Identifiers

Primary DI / UDI-DI
08100322953854 FDA UDI
FDA Product Code
QXT FDA UDI
GMDN Term
TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3115 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: TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay

Procise IFX by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chembio Diagnostic Systems

Sources (1)

  • FDA UDI 579dc0c1-fc4f-4505-b93d-1e8d0450f35b 34 fields · synced Jun 8, 2026