Anti-dsDNA
- Primary DI
- 00845533003117
- Brand
- Anti-dsDNA
- Company
- ZEUS SCIENTIFIC, INC.
- Model
- SM2Z2881G
- Catalog number
- SM2Z2881G
- Device description
- The Anti-dsDNA is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.
- Published
- 2026-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00845533003117 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00845533003117 | 00845533003117 | 845533003117 | 0845533003117 |
GMDN Terms#
| Term | Definition |
|---|---|
| Double stranded DNA antibody (anti-dsDNA) 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 antibodies to double stranded DNA (anti-dsDNA) 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 |
Regulatory Flags#
- DUNS number
- 080953946
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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|---|---|---|---|---|
| 00845533003551 | Legionella pneumophila (Group 1-6) | FA15001 | FA15001 | 2026-05-26 |
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| 00845533003575 | Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM | FA9151M | FA9151M | 2026-05-26 |
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| 00845533003506 | Alegria Flash PR3 Control Kit | CL28141CK | CL28141CK | 2026-05-15 |
| 00845533003513 | Alegria Flash MPO | CL28131 | CL28131 | 2026-05-15 |
| 00845533003520 | Alegria Flash MPO Control Kit | CL28131CK | CL28131CK | 2026-05-15 |
| 00845533003537 | Alegria Flash GBM | CL28151 | CL28151 | 2026-05-15 |
| 00845533003544 | Alegria Flash GBM Control Kit | CL28151CK | CL28151CK | 2026-05-15 |
| 00845533003476 | Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT) | FA7001T | FA7001T | 2026-04-15 |
| 00845533002851 | Anti-SARS-CoV-2 IgG | SM9Z7901G | SM9Z7901G | 2026-04-01 |
| 00845533002868 | Anti-SARS-CoV-2 Total | SM9Z7901 | SM9Z7901 | 2026-04-01 |
| 00845533003100 | Anti-dsDNA | 2Z2881G | 2Z2881G | 2026-04-01 |
| 00845533003124 | Anti-EBV EA IgG | 9Z9481G | 9Z9481G | 2026-04-01 |
| 00845533003131 | Anti-EBV EA IgG | SM9Z9481G | SM9Z9481G | 2026-04-01 |
| 00845533003148 | ENA Screen | 2Z2851G | 2Z2851G | 2026-04-01 |
| 00845533003155 | ENA Screen | SM2Z2851G | SM2Z2851G | 2026-04-01 |
| 00845533003162 | Anti-Gliadin IgA | 2Z61001A | 2Z61001A | 2026-04-01 |
| 00845533003179 | Anti-Gliadin IgA | SM2Z61001A | SM2Z61001A | 2026-04-01 |