FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMUNO-TROL
DI: 03760170782027
·
Model: CONNECTIVE 1
·
THERADIAG SA
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMUNO-TROL
- Primary DI
- 03760170782027
- Version / Model
- CONNECTIVE 1
- Catalog Number
- HM 060US-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
- 2
- Public Version Date
- 2022-03-08
- Public Version Status
- Update
- Public Device Record Key
- 7666a7a1-d441-43c2-9e8d-508e1b264bcd
Device Description
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid– Level 1 DNA* , Anti-Sjögren’s Syndrom antigen A - 60 kDa. SS-A 60, Anti-Sjögren’s Syndrom antigen A - 52 kDa SS-A 52 , Anti-Sjögren’s Syndrom antigen B SS-B, Anti-Smith antigen Sm , Anti-Smith and ribonucleoproteins antigens Sm/RNP , Anti- U1 ribonucleoproteins antigen U1RNP .
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 |
|---|---|---|---|---|
| 46080 | Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760170782027 | GS1 |
Customer Contacts
- Phone
- 0164621012
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius