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Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. FDA UDI
- Model / Reference
- 720-340 FDA UDI
- Description
- ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. FDA UDI
Identifiers
- Catalog Number
- 720-340 FDA UDI
- Primary DI / UDI-DI
- B3507203400 FDA UDI
- FDA Product Code
- LGC FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- ASI HSV IgG EIA Test — Arlington Scientific, Inc. · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Pointe Scientific, Inc. HSV-1 & 2 IgG — POINTE SCIENTIFIC, INC. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
- HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B) — MONOBIND, INC. · Class II
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
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 6227b622-6798-42fe-aaa3-b29bd75b0748 35 fields · synced Jun 8, 2026