IFA ANA Hep-2 Test System
- Primary DI
- 00845533001380
- Brand
- IFA ANA Hep-2 Test System
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- FA2401
- Catalog number
- FA2401
- Device description
- The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and 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
- true
Related Records
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533001380 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533001380 | 00845533001380 | 845533001380 | 0845533001380 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple systemic lupus erythematosus (SLE)-associated antibody 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 antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen, using an fluorescent immunoassay 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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|---|---|---|---|---|
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| 00845533002882 | Cardiac Muscle (Rat) | 5448RL | 5448RL | 2026-02-18 |
| 00845533002899 | Adrenal Cortex (Primate) | 6448L | 6448L | 2026-02-18 |
| 00845533002905 | Ovary (Primate) | 6648L | 6648L | 2026-02-18 |
| 00845533002912 | Testes (Primate) | 6748L | 6748L | 2026-02-18 |
| 00845533002929 | Mumps Virus IgG | I-MUV01G | I-MUV01G | 2026-02-18 |
| 00845533002936 | NTx Urine | NTx9006 | 2026-02-18 | |
| 00845533002943 | NTx Serum | NTx9021 | NTx9021 | 2026-02-18 |
| 00845533002950 | Anti-Borrelia VlsE1/pepC10 IgG/IgM | PF-SM3Z9661 | PF-SM3Z9661 | 2026-02-18 |
| 00845533002967 | ANA Screen | 2Z29001G | 2Z29001G | 2026-02-18 |
| 00845533002974 | ANA Screen | SM2Z29001G | SM2Z29001G | 2026-02-18 |
| 00845533002981 | ANCA Screen | 2Z9681G | 2Z9681G | 2026-02-18 |
| 00845533002998 | ANCA Screen | SM2Z9681G | SM2Z9681G | 2026-02-18 |
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