ELISA PR-3 Smart Kit Test System
- Primary DI
- 00845533000963
- Brand
- ELISA PR-3 Smart Kit Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM2Z9691G
- Catalog number
- SM2Z9691G
- Device description
- The ZEUS ELISA Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 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). ANCA may be associated with autoimmune disorders such as Wegener’s granulomatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533000963 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533000963 | 00845533000963 | 845533000963 | 0845533000963 |
GMDN Terms
| Term | Definition |
|---|---|
| Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-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 proteinase 3 (PR3) in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 080953946
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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