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Simplexa™ VZV Swab Direct

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
Simplexa™ VZV Swab Direct FDA UDI
Generic Name
Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Model / Reference
MOL3655 FDA UDI

Identifiers

Catalog Number
MOL3655 FDA UDI
Primary DI / UDI-DI
20816101025712 FDA UDI
510(k) Number
K192376 FDA UDI
FDA Product Code
PGI 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
866.3309 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 Swab 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

K192376 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI b2c2d213-1ff0-43e5-a70c-4e219dd3ec7f 36 fields · synced Jun 9, 2026