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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
Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI
Device Name
ANA Positive Control FDA UDI
Model / Reference
2201 FDA UDI
Description
ANA Positive Control FDA UDI

Identifiers

Catalog Number
2201 FDA UDI
Primary DI / UDI-DI
00845714001932 FDA UDI
510(k) Number
K883883 FDA UDI
K883915 FDA UDI
K883949 FDA UDI
FDA Product Code
DBL FDA UDI
LKJ FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
866.5100 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

Yes

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: Multiple antinuclear antibody (ANA) screening IVD, control

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

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening IVD, control.

Cleared under the same submission

K883883 also covers:

K883915 also covers:

K883949 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 6d15965a-cfe2-4aa8-aad4-0bc583ae0d40 38 fields · synced Sep 17, 2026