FDA UDI
In Commercial Distribution
🇺🇸 United States
AESKULISA® DGP-Check
DI: 04250289503679
·
Model: 3515
·
Aesku.Diagnostics GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESKULISA® DGP-Check
- Primary DI
- 04250289503679
- Version / Model
- 3515
- 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
- b08dbbae-c3a2-44ac-9213-abca49a1f2c8
Device Description
AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy).
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 |
|---|---|---|---|---|
| MST | Antibodies, Gliadin | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54812 | Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250289503679 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132082 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius