Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA 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
- DACD 1444-2 FDA UDI
- Description
- AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA 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
- 1444-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000046 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
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
AccuDiag ™ by Diagnostic Automation, Inc. — Class II — 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).
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- 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
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- QMedix™ — Diagnostic Automation, 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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 9b32b834-fdb9-435f-8cee-9a5f2b0202e8 37 fields · synced Jun 1, 2026