FDA UDI
In Commercial Distribution
🇺🇸 United States
Myeloperoxidase IgG ELISA
DI: 04048474027761
·
Model: EIA-2776
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Myeloperoxidase IgG ELISA
- Primary DI
- 04048474027761
- Version / Model
- EIA-2776
- Catalog Number
- EIA-2776
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-29
- Public Version
- 1
- Public Version Date
- 2023-09-06
- Public Version Status
- New
- Public Device Record Key
- 9837d7ec-db72-4a93-b9c5-83a3122dd5af
Device Description
The DRG Myeloperoxidase (MPO) IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibody to myeloperoxidase 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).
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55068 | Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA) | 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 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 | 04048474027761 | GS1 |
Customer Contacts
- Phone
- 973-564-7555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964446 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius