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CMV Negative Control

FDA UDI

Class II (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
CMV Negative Control FDA UDI
Generic Name
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control FDA UDI
Model / Reference
CMN-2010 FDA UDI

Identifiers

Catalog Number
CMN-2010 FDA UDI
Primary DI / UDI-DI
B110CMN20100 FDA UDI
510(k) Number
K880679 FDA UDI
FDA Product Code
GQH FDA UDI
GMDN Term
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control 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

No

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, controlCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control

CMV Negative Control by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control.

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 bf9cbf80-9d71-41d1-a825-1338e7a7c127 36 fields · synced May 30, 2026