Identity
- Trade Name
- HSV-1 ELISA IgG Cutoff Calibrator FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator FDA UDI
- Model / Reference
- EL0903 FDA UDI
Identifiers
- Catalog Number
- EL0903 FDA UDI
- Primary DI / UDI-DI
- 10816101022073 FDA UDI
- 510(k) Number
- K993754 FDA UDI
- FDA Product Code
- MXJ FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator
HSV-1 ELISA IgG Cutoff Calibrator by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibrator.
- Alinity — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
K993754 also covers:
- DxSelect™ - 10X Wash Buffer — DiaSorin Molecular LLC
- DxSelect™ - Stop Reagent — DiaSorin Molecular LLC
- DxSelect™ - Substrate Reagent — DiaSorin Molecular LLC
- DxSelect™ Sample Diluent — DiaSorin Molecular LLC
- HSV ELISA Negative Control — DiaSorin Molecular LLC
- HSV Serum Panel — DiaSorin Molecular LLC
- HSV-1 ELISA IgG Conjugate — DiaSorin Molecular LLC
- HSV-1 ELISA IgG High Positive Control — DiaSorin Molecular LLC
- HSV-1 ELISA IgG Low Positive Control — DiaSorin Molecular LLC
- HerpeSelect® 1 ELISA IgG — DiaSorin Molecular LLC
- HerpeSelect® 1 ELISA IgG — DiaSorin Molecular LLC
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
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI d12a1b13-688a-49d8-8136-fe645250b415 36 fields · synced Jun 9, 2026