FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
DI: 00845533001984
·
Model: A060L
·
ZEUS SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)
- Primary DI
- 00845533001984
- Version / Model
- A060L
- 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
- 71f217c0-26f8-4954-a0be-855907f76a54
Device Description
The SCIMEDX immunofluorescence assay (IFA) is for the in vitro diagnostic detection of anti-neutrophil cytoplasmic antibodies in human serum using ethanol-fixed human neutrophils as substrate. The test is intended as an aid in the diagnosis of Granulomatosis with Polyangiitis (GPA), idiopathic crescentic glomerulonephritis, microscopic polyarteritis, and pulmonary renal syndrome.
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 | 00845533001984 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962360 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius