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DNA (ds) IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
DNA (ds) IgG ELISA FDA UDI
Generic Name
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The dsDNA ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. FDA UDI
Model / Reference
EIA-2774 FDA UDI
Description
The dsDNA ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. FDA UDI

Identifiers

Catalog Number
EIA-2774 FDA UDI
Primary DI / UDI-DI
00840239027740 FDA UDI
510(k) Number
K933267 FDA UDI
FDA Product Code
LJM FDA UDI
GMDN Term
Double stranded DNA antibody (anti-dsDNA) 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

DNA (ds) 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 d731a947-9b54-4568-87a3-16bf9f341e2c 38 fields · synced May 30, 2026