FDA UDI
In Commercial Distribution
🇺🇸 United States
ANTI-MPO (pANCA)
DI: 04260157080188
·
Model: ORG519
·
ORGENTEC Diagnostika GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANTI-MPO (pANCA)
- Primary DI
- 04260157080188
- Version / Model
- ORG519
- Catalog Number
- ORG519
- Company Name
- ORGENTEC Diagnostika GmbH
- Labeler DUNS
- 328133103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 440c627e-725d-48ce-a50d-96107ea05885
Device Description
Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional 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
- 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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260157080188 | GS1 |
Customer Contacts
- Phone
- +49061319258
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974701 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius