FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNO-TROL
DI: 03760170782126
·
Model: CELIAC IgA
·
THERADIAG SA
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMUNO-TROL
- Primary DI
- 03760170782126
- Version / Model
- CELIAC IgA
- Catalog Number
- HM 070US-2X05
- Company Name
- THERADIAG SA
- Labeler DUNS
- 391123478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- f2fc046c-905f-473a-a286-6d3c8877738d
Device Description
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-gliadin IgA isotypes Glia IgA , anti-transglutaminase IgA isotype tTG IgA , anti-deamidated gliadin peptide IgA isotype DPG IgA .
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
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54815 | Multiple Coeliac disease-associated antibody IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen. 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 | 03760170782126 | GS1 |
Customer Contacts
- Phone
- 0164621012
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius