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MERIFLUOR VZV (Vericella-Zoster Virus)

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
MERIFLUOR VZV (Vericella-Zoster Virus) FDA UDI
Generic Name
Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Device Name
MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture. FDA UDI
Model / Reference
500113 FDA UDI
Description
MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture. FDA UDI

Identifiers

Catalog Number
500113 FDA UDI
Primary DI / UDI-DI
00840733101212 FDA UDI
510(k) Number
K841526 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

MERIFLUOR VZV (Vericella-Zoster Virus) by Meridian Bioscience, Inc. — 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
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI e735a67b-0db8-4815-8553-eaa5d2825f26 37 fields · synced May 30, 2026