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Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System

FDA UDI

Class II (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System FDA UDI
Generic Name
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
Model / Reference
CM-2012 FDA UDI

Identifiers

Catalog Number
CM-2012 FDA UDI
Primary DI / UDI-DI
B110CM20120 FDA UDI
510(k) Number
K880679 FDA UDI
FDA Product Code
GQH FDA UDI
GMDN Term
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent 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

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

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, reagentCytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent

Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID

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 467bbae8-68d2-44d3-b577-b50ba8ce79a2 36 fields · synced May 31, 2026