AccessGUDID - DEVICE: Proteinase-3 IgG ELISA (00840239027788)

GUDID

Device Identifier (DI) Information

Brand Name: Proteinase-3 IgG ELISA
Version or Model: EIA-2778
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-2778
Company Name: DRG International Inc

Primary DI Number: 00840239027788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55073	Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen, using a multiplex method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964448	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 843096ae-19ce-4eae-b09a-d59dae8ca91d
Public Version Date: August 31, 2023
Public Version Number: 1
DI Record Publish Date: August 23, 2023