Identity
- Trade Name
- Simplexa™ VZV Direct FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- MOL3650 FDA UDI
Identifiers
- Catalog Number
- MOL3650 FDA UDI
- Primary DI / UDI-DI
- 20816101025774 FDA UDI
- 510(k) Number
- K190219 FDA UDI
- FDA Product Code
- PLO FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3970 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
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
Category: Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Simplexa™ VZV Direct by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT).
Cleared under the same submission
K190219 also covers:
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 d213d7b0-4aff-4371-94c0-249f38e04fd6 36 fields · synced Jun 9, 2026