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ANA Screen IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
ANA Screen IgG ELISA FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to the enclosed instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. FDA UDI
Model / Reference
EIA-2773 FDA UDI
Description
The ANA Screen ELISA test system is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to the enclosed instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. FDA UDI

Identifiers

Catalog Number
EIA-2773 FDA UDI
Primary DI / UDI-DI
00840239027733 FDA UDI
510(k) Number
K940362 FDA UDI
FDA Product Code
LLL FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
Not 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

Yes

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

Yes

FDA UDI

ANA Screen IgG ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG International, Inc.

Sources (1)

  • FDA UDI 903d92bc-caa3-4682-a863-b380f931ab95 38 fields · synced May 30, 2026