FDA UDI
In Commercial Distribution
🇺🇸 United States
AtheNA Multi-Lyte® AIV Plus Test System
DI: 00845533000024
·
Model: A96101
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AtheNA Multi-Lyte® AIV Plus Test System
- Primary DI
- 00845533000024
- Version / Model
- A96101
- Catalog Number
- A96101
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 13e315e2-60e8-4e15-91fd-f9f40d78c339
Device Description
The ZEUS AtheNA Multi-Lyte® Autoimmune Vasculitis (AIV) Plus Test System is intended for the qualitative and semi-quantitative detection of IgG class antibody to three separate antigens; Glomerular Basement Membrane (GBM), Myeloperoxidase (MPO) and Proteinase 3(PR-3) 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 selected autoantibodies. MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulomatosis, ICGN, MPA and PRS. Anti-GBM antibodies aid in the diagnosis of Goodpasture’s syndrome. This test is for In Vitro diagnostic use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54855 | Multiple vasculitis-associated antibody IVD, kit, multiplex | 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 a multiplex method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000024 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius