← Back to catalogue

ImmunoDOT Autoimmunity Panel 1

FDA UDI

Class II (US FDA UDI)

by Genbio

Identity

Trade Name
ImmunoDOT Autoimmunity Panel 1 FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI
Device Name
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. FDA UDI
Model / Reference
800-5125 FDA UDI
Description
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. FDA UDI

Identifiers

Catalog Number
5125 FDA UDI
Primary DI / UDI-DI
00613745051253 FDA UDI
510(k) Number
K896347 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 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

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: Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

ImmunoDOT Autoimmunity Panel 1 by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K896347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Genbio

Sources (1)

  • FDA UDI 23a39de6-933a-4183-93ab-a124453ac9b4 38 fields · synced May 30, 2026