Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)
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Basic Information
- Brand Name
- Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)
- Primary DI
- 00845533001991
- Version / Model
- A060PL
- Catalog Number
- A060PL
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-11
- Public Version
- 1
- Public Version Date
- 2025-06-19
- Public Version Status
- New
- Public Device Record Key
- 58bc979a-ab3e-4165-a78c-951a08095e65
Device Description
Standard IFA methods allow for the observation of several different patterns. Two patterns that have been well defined are C-ANCA and P-ANCA. The P-ANCA pattern shows an uneven granular, staining of the cytoplasm. During the 2nd International ANCA Workshop it was agreed that these two different patterns should be used to subclassify the antibodies. Anti-neutrophil cytoplasmic antibody (ANCA)antibody detection by IFA methods has been a useful aid in the assessment of patient diagnosis, and to a certain extent their prognosis and response to therapy. Although there has been much work done with the IFA ANCA, the availability of an MPO-specific enzyme immunoassay (EIA) test has further enhanced the overall picture. The use of EIA and IFA together allows for the best possible patient assessment. The MPO and PR3 EIA allows for a very quick qualitative as well as quantitative report.
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
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 |
|---|---|---|---|---|
| 55061 | Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533001991 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962360 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius