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Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM 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
- 720-350 FDA UDI
- Description
- ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM 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
- 720-350 FDA UDI
- Primary DI / UDI-DI
- B3507203500 FDA UDI
- 510(k) Number
- K002262 FDA UDI
- FDA Product Code
- LGC FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) 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 IgM 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 M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- ELISA HSV-1 & 2 IgM Test System — ZEUS SCIENTIFIC, INC.
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- ELISA HSV-1 & 2 IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B) — MONOBIND, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B) — MONOBIND, INC. · Class II
- QMedix™ — Diagnostic Automation, Inc. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
Cleared under the same submission
K002262 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
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 0214fff4-cbe0-4abc-945b-51b7e9126050 36 fields · synced Jun 8, 2026