FDA UDI
In Commercial Distribution
🇺🇸 United States
TGF-Beta 2 ELISA
DI: 04048474023961
·
Model: EIA-2396
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TGF-Beta 2 ELISA
- Primary DI
- 04048474023961
- Version / Model
- EIA-2396
- Catalog Number
- EIA-2396
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 1
- Public Version Date
- 2024-12-02
- Public Version Status
- New
- Public Device Record Key
- d1fcf44a-f45b-41f6-8f4d-9231678a9aed
Device Description
The DRG TGF-ß2 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF-ß2 in serum, plasma 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 | 04048474023961 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius