FDA UDI
In Commercial Distribution
🇺🇸 United States
AESKULISA® dsDNA-G
DI: 04250289500647
·
Model: 3142
·
Aesku.Diagnostics GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESKULISA® dsDNA-G
- Primary DI
- 04250289500647
- Version / Model
- 3142
- Company Name
- Aesku.Diagnostics GmbH & Co. KG
- Labeler DUNS
- 341714388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 40511a2d-fc0d-4b0e-b1ea-9c5ece4ab3d5
Device Description
AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LSW | Anti-Dna Antibody, Antigen And Control | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54902 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250289500647 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041628 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius