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Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System

FDA UDI

Class I (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System FDA UDI
Generic Name
Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
Model / Reference
CB-3306 FDA UDI

Identifiers

Catalog Number
CB-3306 FDA UDI
Primary DI / UDI-DI
B110CB33060 FDA UDI
FDA Product Code
GNN FDA UDI
GMDN Term
Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3145 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent.

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 21e411b0-4e68-426a-b667-103f260ea5a2 34 fields · synced Jun 8, 2026