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Proteinase-3 IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Proteinase-3 IgG ELISA FDA UDI
Generic Name
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex FDA UDI
Device Name
The DRG ELISA Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. The test 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). ANCA may be associated with autoimmune disorders such as Wegener's granulomatosis, ICGN, MPA and PRS FDA UDI
Model / Reference
EIA-2778 FDA UDI
Description
The DRG ELISA Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. The test 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). ANCA may be associated with autoimmune disorders such as Wegener's granulomatosis, ICGN, MPA and PRS FDA UDI

Identifiers

Catalog Number
EIA-2778 FDA UDI
Primary DI / UDI-DI
00840239027788 FDA UDI
510(k) Number
K964448 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex 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: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex

Proteinase-3 IgG ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex.

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 843096ae-19ce-4eae-b09a-d59dae8ca91d 37 fields · synced May 31, 2026