Duns Number:878252071
Device Description: AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materi AccuDiag ™ ANCA Screen IgG ELISA Kit A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplasmic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplasmic antibodies to proteinase-3 (PR3).
Catalog Number
1681-2
Brand Name
AccuDiag ™
Version/Model Number
DACD-1681-2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MOB
Product Code Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Public Device Record Key
d7b3d0a4-4cf9-4e6b-85d9-43a39054451b
Public Version Date
August 17, 2021
Public Version Number
1
DI Record Publish Date
August 09, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |