← Back to catalogue

IMMUNOWELL JCV IgG Test

FDA UDI

Class II (US FDA UDI)

by Genbio

Identity

Trade Name
IMMUNOWELL JCV IgG Test FDA UDI
Generic Name
JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is intended for use, in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations. FDA UDI
Model / Reference
804-3810 FDA UDI
Description
The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is intended for use, in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations. FDA UDI

Identifiers

Catalog Number
3810 FDA UDI
Primary DI / UDI-DI
00613745002231 FDA UDI
FDA Product Code
OYP FDA UDI
GMDN Term
JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3336 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

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: JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)

IMMUNOWELL JCV IgG Test by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Genbio

Sources (1)

  • FDA UDI 4d603c21-eb81-4906-a8a7-95f7f931c472 37 fields · synced Jun 6, 2026