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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
Endomysium antibody (EMA) IVD, control FDA UDI
Device Name
EMA Positive Control FDA UDI
Model / Reference
2250 FDA UDI
Description
EMA Positive Control FDA UDI

Identifiers

Catalog Number
2250 FDA UDI
Primary DI / UDI-DI
00845714003943 FDA UDI
510(k) Number
K060157 FDA UDI
K912551 FDA UDI
FDA Product Code
MVM FDA UDI
DBL FDA UDI
GMDN Term
Endomysium antibody (EMA) IVD, control 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

Yes

FDA UDI

Category: Endomysium antibody (EMA) IVD, control

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

Cleared under the same submission

K060157 also covers:

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 e70fc0a4-b8b3-4eba-90cb-4ac40c70fac1 38 fields · synced Sep 17, 2026