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Light Diagnostics™ Varicella- Zoster Virus DFA Kit

FDA UDI

Class II (US FDA UDI)

by Emd Millipore Corporation

Identity

Trade Name
Light Diagnostics™ Varicella- Zoster Virus DFA Kit FDA UDI
Generic Name
Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Device Name
Varicella- Zoster Virus DFA Kit FDA UDI
Model / Reference
3430 FDA UDI
Description
Varicella- Zoster Virus DFA Kit FDA UDI

Identifiers

Catalog Number
3430 FDA UDI
Primary DI / UDI-DI
08436037124716 FDA UDI
510(k) Number
K951799 FDA UDI
FDA Product Code
GQX FDA UDI
GMDN Term
Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3900 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

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

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) antigen IVD, kit, direct fluorescent test (DFT)

Light Diagnostics™ Varicella- Zoster Virus DFA Kit by Emd Millipore Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emd Millipore Corporation

Sources (1)

  • FDA UDI ee110375-845b-4df7-8058-6a20c3ac912d 36 fields · synced May 31, 2026