FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TGF-B1 ELISA
DI: 00840239018649
·
Model: EIA-1864
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TGF-B1 ELISA
- Primary DI
- 00840239018649
- Version / Model
- EIA-1864
- Catalog Number
- EIA-1864
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 2
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- e66d8fff-350e-4bca-91fe-1ce4ede46a2e
- Distribution End Date
- 2025-07-11
Device Description
The DRG TGF-ß1 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF-ß1 in serum and cell culture supernatant.
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 |
|---|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | Clinical Chemistry | 862.1370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65493 | Transforming growth factor beta protein 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 transforming growth factor beta (TGF-beta) protein in a clinical specimen, using an enzyme immunoassay (EIA) method. TGF-beta-1 and TGF-beta-2 are cytokines involved in various biological processes and are associated with developmental, neurological, and immune system disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239018649 | GS1 |
Customer Contacts
- Phone
- 9735647555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius