Identity
- Trade Name
- Ascaris IgG ELISA FDA UDI
- Generic Name
- Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the qualitative screening of serum or plasma IgG antibodies to Ascaris using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique. FDA UDI
- Model / Reference
- EIA-5854 FDA UDI
- Description
- For the qualitative screening of serum or plasma IgG antibodies to Ascaris using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique. FDA UDI
Identifiers
- Catalog Number
- EIA-5854 FDA UDI
- Primary DI / UDI-DI
- 04048474058543 FDA UDI
- FDA Product Code
- MDT FDA UDI
- GMDN Term
- Ascaris lumbricoides 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
Yes
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
Yes
FDA UDI
Category: Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Ascaris IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Ascaris IgG ELISA — DRG International, Inc. · Class I
- AccuDiag ™ — Diagnostic Automation, Inc. · 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
Sources (1)
- FDA UDI 5c097913-c344-4bf1-973c-d3c616401de6 36 fields · synced Jun 1, 2026