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ANCA Screen IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
ANCA Screen IgG ELISA FDA UDI
Generic Name
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The ANCA Screen ELISA test system is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. FDA UDI
Model / Reference
EIA-2777 FDA UDI
Description
The ANCA Screen ELISA test system is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. FDA UDI

Identifiers

Catalog Number
EIA-2777 FDA UDI
Primary DI / UDI-DI
00840239027771 FDA UDI
510(k) Number
K964448 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA) 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

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

Category: Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K964448 also covers:

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 131dd1d5-849c-407a-9265-2c3be4ab0ff9 37 fields · synced May 30, 2026