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CL Detect™ Rapid Test

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref CL025

by InBios International, Inc.

Identity

Trade Name
CL Detect Rapid Test for Cutaneous Leishmaniasis FDA UDI
Generic Name
Multiple Leishmania species antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
CL Detect™ Rapid Test EUDAMED
Model / Reference
CL025 EUDAMEDFDA UDI

Identifiers

Catalog Number
CL025 FDA UDI
Primary DI / UDI-DI
++B379CL025TT EUDAMED
B379CL0251 FDA UDI
Basic UDI-DI
B-++B379CL025TT EUDAMED
FDA Product Code
PIT FDA UDI
EMDN Code
W0105090499 PARASITES - RT & POC - OTHER EUDAMED
GMDN Term
Multiple Leishmania species antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
866.3870 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

CL Detect™ Rapid Test by InBios International, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
InBios International, Inc.
EUDAMED SRN
US-MF-000020625
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (2)

  • EUDAMED 236794fc-6ccc-4480-9efb-ee9c9082d7be 61 fields · synced Jul 13, 2026
  • FDA UDI 9784e912-dc34-4731-890d-3839353571e5 33 fields · synced May 30, 2026