Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Captia™ Toxoplasma gondii IgM FDA UDI
- Model / Reference
- 2325150 FDA UDI
- Description
- Captia™ Toxoplasma gondii IgM FDA UDI
Identifiers
- Catalog Number
- 2325150 FDA UDI
- Primary DI / UDI-DI
- 05391516743389 FDA UDI
- 510(k) Number
- K920702 FDA UDI
- FDA Product Code
- LGD FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3780 FDA UDI
- 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
No
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: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Trinity Biotech by Clark Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- PLATELIA — Bio-Rad · Class II
- VIDAS® TOXO IgM — BIOMERIEUX , INC. · Class II
- ELISA T. gondii IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- Toxo IgM AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- Toxo IgM AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
- ASI Toxoplasma IgM EIA Test — Arlington Scientific, Inc. · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
Cleared under the same submission
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI a5380da2-f69c-451f-a260-18c29cc5edc4 38 fields · synced May 30, 2026