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IFA Mosaic: Coxsackie virus A Types (IgG)

FDA UDI

Class I (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
IFA Mosaic: Coxsackie virus A Types (IgG) FDA UDI
Generic Name
Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
FI 2730-2005-2 G FDA UDI

Identifiers

Primary DI / UDI-DI
04049016061175 FDA UDI
FDA Product Code
GNM FDA UDI
GMDN Term
Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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

No

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

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 A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

IFA Mosaic: Coxsackie virus A Types (IgG) by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coxsackie A/B virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI d108daa5-0dd6-4a7f-9f64-3f79f3fd140b 33 fields · synced May 31, 2026