Identity
- Trade Name
- NovaLisa Strongyloides FDA UDI
- Generic Name
- Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or heparin). FDA UDI
- Model / Reference
- STRO0690 FDA UDI
- Description
- The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or heparin). FDA UDI
Identifiers
- Catalog Number
- STRO0690 FDA UDI
- Primary DI / UDI-DI
- ENTISTRO06900 FDA UDI
- FDA Product Code
- MDT FDA UDI
- GMDN Term
- Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3850 FDA UDI
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
NovaLisa Strongyloides by Gold Standard Diagnostics Frankfurt GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Strongy DetectTM IgG ELISA — InBios International, Inc.
- AccuDiag ™ — Diagnostic Automation, Inc. · Class I
- Strongyloides IgG ELISA — DRG International, Inc. · Class I
- Strongyloides IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class I
- Strongyloides IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Anti-Strongyloides ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Frankfurt GmbH
Sources (1)
- FDA UDI 3e0f84a3-4091-4926-a4b3-9e7d9ce7fb3c 36 fields · synced Jun 8, 2026