FDA UDI
In Commercial Distribution
🇺🇸 United States
T3 Total ELISA
DI: 00840239045690
·
Model: EIA-4569
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- T3 Total ELISA
- Primary DI
- 00840239045690
- Version / Model
- EIA-4569
- Catalog Number
- EIA-4569
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-25
- Public Version
- 1
- Public Version Date
- 2023-09-04
- Public Version Status
- New
- Public Device Record Key
- f8f74d11-ff41-4b91-bbd2-3f8d2bb4e5b5
Device Description
The DRG T3 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total T3 (triiodothyronine) in serum and plasma
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | Clinical Chemistry | 862.1710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61252 | Multiple thyroid marker 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 multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239045690 | GS1 |
Customer Contacts
- Phone
- 9735647555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius