FDA UDI
In Commercial Distribution
🇺🇸 United States
AESKULISA tTg-G New Generation
DI: 04250289502887
·
Model: 30-7504US
·
Aesku.Diagnostics GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESKULISA tTg-G New Generation
- Primary DI
- 04250289502887
- Version / Model
- 30-7504US
- Catalog Number
- 30-7504US
- 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
- 2017-02-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 418f6734-cbff-4c24-ac5b-e7442a168294
Device Description
The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. 30'+30'+30' automation incubation.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55223 | Tissue transglutaminase antibody 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 tissue transglutaminase (anti-tTG) 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 | 04250289502887 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042644 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius