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Immco Diagnostics

FDA UDI

Class II (US FDA UDI)

by Immco Diagnostics, Inc.

Identity

Trade Name
IMMCO DIAGNOSTICS FDA UDI
Generic Name
Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD FDA UDI
Device Name
IgA/IgG FITC Conjugate w/EB FDA UDI
Model / Reference
2113-15 FDA UDI
Description
IgA/IgG FITC Conjugate w/EB FDA UDI

Identifiers

Catalog Number
2113-15 FDA UDI
Primary DI / UDI-DI
00845714003066 FDA UDI
510(k) Number
K912551 FDA UDI
FDA Product Code
DBL FDA UDI
GMDN Term
Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 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: Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD

Immco Diagnostics by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD.

Cleared under the same submission

K912551 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immco Diagnostics, Inc.

Sources (1)

  • FDA UDI 7cfe7eca-cf09-4b86-b17d-4c31c9475fda 38 fields · synced Sep 17, 2026