Identity
- Trade Name
- Trichinella spiralis IgG ELISA FDA UDI
- Generic Name
- Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Trichinella spiralis IgG ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Trichinella, in samples of human serum or plasma. This test is intended to be performed by trained medical technologists only. FDA UDI
- Model / Reference
- EIA-3521 FDA UDI
- Description
- The Trichinella spiralis IgG ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to Trichinella, in samples of human serum or plasma. This test is intended to be performed by trained medical technologists only. FDA UDI
Identifiers
- Catalog Number
- EIA-3521 FDA UDI
- Primary DI / UDI-DI
- 00840239035219 FDA UDI
- FDA Product Code
- MDT FDA UDI
- GMDN Term
- Trichinella spiralis 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: Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Trichinella spiralis IgG ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Trichinella spiralis IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class I
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- AccuDiag ™ — Diagnostic Automation, Inc. · Class I
- Trichinella spiralis IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Trichinella Antibody 96 Tests — Scimedx Corp. · Class I
- Trichinella spiralis IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Trichinella spiralis IgG ELISA — DRG International, 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
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 8ede60cb-b37a-44f6-903c-a9430661b5e1 36 fields · synced May 30, 2026