AESKULISA® Scl-70
- Primary DI
- 04250289500531
- Brand
- AESKULISA® Scl-70
- Company
- Aesku.Diagnostics GmbH & Co. KG
- Model
- 3111
- Device description
- AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis.
- Published
- 2016-09-27
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04250289500531 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04250289500531 | 04250289500531 | 4250289500531 |
GMDN Terms#
| Term | Definition |
|---|---|
| Scleroderma-70 antibody (anti-Scl-70) 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 scleroderma-70 (anti-Scl-70) in a clinical specimen, using an enzyme immunoassay (EIA) method. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 | 0 |
Regulatory Flags#
- DUNS number
- 341714388
- 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04250289502849 | AESKULISA® ß2-Glyco-Check | 30-7215US | 30-7215US | 2017-02-28 |
| 04250289502894 | AESKULISA® ASCA-A | 30-7507US | 30-7507US | 2017-02-28 |
| 04250289502979 | AESKULISA® SS-A | 7107US | 7107US | 2017-02-28 |
| 04250289503006 | AESKULISA® Cenp-B | 7112US | 7112US | 2017-02-28 |
| 04250289504584 | AESKULISA® DGP-A | 30-7513US | 30-7513US | 2017-02-28 |
| 04250289500470 | AESKULISA® snRNP-C | 3105 | 2016-09-27 | |
| 04250289500494 | AESKULISA® SS-A | 3107 | 2016-09-27 | |
| 04250289500548 | AESKULISA® Cenp-B | 3112 | 2016-09-27 | |
| 04250289500838 | AESKULISA® Cardiolipin-A | 3203 | 2016-09-27 | |
| 04250289500852 | AESKULISA® ß2-Glyco-A | 3205 | 2016-09-27 | |
| 04250289500951 | AESKULISA® ß2-Glyco-Check | 3215 | 2016-09-27 | |
| 04250289501491 | AESKULISA® Glia-G | 3502 | 2016-09-27 | |
| 04250289501521 | AESKULISA® ASCA-A | 3507 | 2016-09-27 | |
| 04250289501538 | AESKULISA® ASCA-G | 3508 | 2016-09-27 | |
| 04250289503051 | AESKULISA® Cardiolipin-A | 7203US | 7203US | 2017-02-28 |
| 04250289503624 | AESKULISA® DGP-A | 3513 | 2016-09-27 | |
| 04250289500432 | AESKULISA® ANA-8Pro | 3101 | 2016-09-27 | |
| 04250289500449 | AESKULISA® ENA-6S | 3102 | 2016-09-27 | |
| 04250289500555 | AESKULISA® Jo-1 | 3113 | 2016-09-27 | |
| 04250289500579 | AESKULISA® ANA-HEp-2 | 3115 | 2016-09-27 |