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DENV Detect™ NS1 ELISA

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref DNS1-1

by InBios International, Inc.

Identity

Trade Name
DENV Detect NS1 ELISA FDA UDI
Generic Name
Dengue virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
DENV Detect™ NS1 ELISA EUDAMED
Model / Reference
DNS1-1 EUDAMEDFDA UDI

Identifiers

Catalog Number
DNS1-1 FDA UDI
Primary DI / UDI-DI
++B379DNS11ZK EUDAMED
B379DNS111 FDA UDI
Basic UDI-DI
B-++B379DNS11ZK EUDAMED
FDA Product Code
QCU FDA UDI
EMDN Code
W0105040611 DENGUE VIRUS EUDAMED
GMDN Term
Dengue virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DENV Detect™ NS1 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

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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 90c6fcea-c00d-4be5-b836-a0b640955567 61 fields · synced Aug 2, 2026
  • FDA UDI 35583ee1-9eef-425e-9494-5f4dc46a6e68 33 fields · synced May 29, 2026