Identity
- Trade Name
- Zika ELITe MGB® - EUA FDA UDI
- Generic Name
- Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma. FDA UDI
- Model / Reference
- M800552 FDA UDI
- Description
- The United States (US) Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus RNA in human serum and EDTA plasma. FDA UDI
Identifiers
- Catalog Number
- M800552 FDA UDI
- Primary DI / UDI-DI
- 03661540950018 FDA UDI
- GMDN Term
- Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Zika ELITe MGB® - EUA by ELITechGroup MDX LLC. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas Zika (480 tests) — Roche Diagnostics Corp.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
- Procleix Zika Virus Assay — Grifols Diagnostic Solutions Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI a69bb12c-33eb-4c0c-a5b5-df4520ac332c 35 fields · synced May 30, 2026