Identity
- Trade Name
- IMMULITE® 2000 Systems Herpes I and II IgG FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IMMULITE® 2000 Systems Herpes I and II IgG FDA UDI
- Model / Reference
- 10381333 FDA UDI
- Description
- IMMULITE® 2000 Systems Herpes I and II IgG FDA UDI
Identifiers
- Catalog Number
- L2KHVG6 FDA UDI
- Primary DI / UDI-DI
- 00630414999784 FDA UDI
- 510(k) Number
- K010878 FDA UDI
- FDA Product Code
- LGC FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay 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
No
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
IMMULITE® 2000 Systems Herpes I and II IgG by Siemens Healthcare Diagnostics Products Ltd — 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, chemiluminescent immunoassay.
- Elecsys HSV-2 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV-2 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV-2 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV2 IgG Immunoassay — Roche Diagnostics Corp. · Class II
- Elecsys HSV-1 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV-1 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV-1 IgG — Roche Diagnostics Corp. · Class II
- Elecsys HSV1 IgG Immunoassay — Roche Diagnostics Corp. · 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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 461ea2e0-6c19-430b-a1b5-f6aaa6274ab6 37 fields · synced Jun 6, 2026