Identity
- Trade Name
- Histoplasma DxSelect™ FDA UDI
- Generic Name
- Histoplasma capsulatum antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EL1700 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20816101022230 FDA UDI
- FDA Product Code
- MIZ FDA UDI
- GMDN Term
- Histoplasma capsulatum antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3320 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Histoplasma DxSelect™ by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI 2afa100d-420f-49fd-8586-e374debac0d5 35 fields · synced Jun 9, 2026