Identity
- Trade Name
- ELISA HSV-1 & 2 IgM Test System FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 9Z9771M FDA UDI
- Description
- The ZEUS ELISA Herpes Simplex Virus (HSV) 1 & 2 IgM Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 9Z9771M FDA UDI
- Primary DI / UDI-DI
- 00845533000703 FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
ELISA HSV-1 & 2 IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B) — MONOBIND, INC. · Class II
- Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit — Gold Standard Diagnostics, LLC · 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
- ELISA HSV-1 & 2 IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 95ebbe60-5a4f-4506-8c4f-2c2c04cddf51 35 fields · synced May 30, 2026