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DENV Detect™ IgM Capture ELISA
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref DDMS-1
Identity
- Trade Name
- DENV Detect IgM Capture ELISA FDA UDI
- Generic Name
- Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- DENV Detect™ IgM Capture ELISA EUDAMED
- Model / Reference
- DDMS-1 EUDAMEDDDMS1 FDA UDI
Identifiers
- Catalog Number
- DDMS-1 FDA UDI
- Primary DI / UDI-DI
- ++B379DDMS1ZJ EUDAMEDB379DDMS11 FDA UDI
- Basic UDI-DI
- B-++B379DDMS1ZJ EUDAMED
- FDA Product Code
- OSU FDA UDI
- EMDN Code
- W0105040611 DENGUE VIRUS EUDAMED
- GMDN Term
- Dengue virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3945 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
DENV Detect™ IgM Capture ELISA 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-++B379DDMS1ZJ | 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 7d2a49dd-d802-4d6e-8ab6-bdbf26ca958a 61 fields · synced Jul 17, 2026
- FDA UDI c0a790d3-efc6-4ba0-91bb-b2f54378a2a8 33 fields · synced May 29, 2026