Identity
- Trade Name
- ZIKV Detect™ 2.0 IgM Capture ELISA FDA UDI
- Generic Name
- Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- IVD FDA UDI
Identifiers
- Primary DI / UDI-DI
- B379ZKM21 FDA UDI
- GMDN Term
- Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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: Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
ZIKV Detect™ 2.0 IgM Capture ELISA by InBios International, Inc. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- DPP Zika IgM System — Chembio Diagnostic Systems · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- InBios International, Inc.
Sources (2)
- FDA UDI 4a9c5081-d188-4579-846f-f7b2b26f2dba 32 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026