Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Captia™ HSV 1 Type Specific IgG FDA UDI
- Model / Reference
- 2323800 FDA UDI
- Description
- Captia™ HSV 1 Type Specific IgG FDA UDI
Identifiers
- Catalog Number
- 2323800 FDA UDI
- Primary DI / UDI-DI
- 05391516743310 FDA UDI
- 510(k) Number
- K033105 FDA UDI
- FDA Product Code
- MXJ FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 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: Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) 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 Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
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- HerpeSelect® 1 ELISA IgG — DiaSorin Molecular LLC · Class II
- ELISA HSV gG-1 IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ELISA HSV-1 IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ELISA HSV gG-1 IgG Test System — ZEUS SCIENTIFIC, INC.
- HerpeSelect® 1 ELISA IgG — DiaSorin Molecular LLC · Class II
Cleared under the same submission
K033105 also covers:
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 |
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Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI fb46bb7c-ab67-4fdc-9f5d-8180616feb8a 38 fields · synced May 30, 2026