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CMV IgG Test System, 120 Tests

FDA UDI

Class II (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
CMV IgG Test System, 120 Tests FDA UDI
Generic Name
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
CMG-120 FDA UDI

Identifiers

Catalog Number
CMG-120 FDA UDI
Primary DI / UDI-DI
B110CMG1200 FDA UDI
510(k) Number
K880679 FDA UDI
FDA Product Code
GQH FDA UDI
GMDN Term
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3175 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: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

CMV IgG Test System, 120 Tests by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K880679 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bion Enterprises, Ltd.

Sources (1)

  • FDA UDI b7b8c7c6-8f70-488a-bd51-c581d85a0056 36 fields · synced Jun 7, 2026