Identity
- Trade Name
- Kalazar Detect Rapid Test for Visceral Leishmaniasis FDA UDI
- Generic Name
- Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Kalazar Detect™ Rapid Test EUDAMED
- Model / Reference
- INS025 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- INS025 FDA UDI
- Primary DI / UDI-DI
- ++B379INS0251J EUDAMEDB379INS0251 FDA UDI
- Basic UDI-DI
- B-++B379INS0251J EUDAMED
- FDA Product Code
- LOO FDA UDI
- EMDN Code
- W0105090499 PARASITES - RT & POC - OTHER EUDAMED
- GMDN Term
- Leishmania donovani immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
Kalazar 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-++B379INS0251J | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 a5812a00-c24e-4e86-b843-cbcaf88fe4f9 61 fields · synced Jun 19, 2026
- FDA UDI 127afc7f-80b4-4e42-8ece-d0da82f2a8b2 33 fields · synced May 29, 2026