FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA MPO Test System
DI: 00845533000840
·
Model: 2Z9671G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA MPO Test System
- Primary DI
- 00845533000840
- Version / Model
- 2Z9671G
- Catalog Number
- 2Z9671G
- 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
- 3
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 8bee87f0-edb1-402f-bc77-e0285681c9e5
Device Description
The ZEUS ELISA Myeloperoxidase (MPO) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloperoxidase in human serum. This 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). MPO-ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.
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 |
|---|---|---|---|---|
| 59236 | Myeloperoxidase (MPO) IVD, kit, enzyme immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of myeloperoxidase (MPO) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000840 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius