FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B.R.A.H.M.S Tg-pluS RIA
DI: 04260157631106
·
Model: 110.1
·
B.R.A.H.M.S GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B.R.A.H.M.S Tg-pluS RIA
- Primary DI
- 04260157631106
- Version / Model
- 110.1
- Company Name
- B.R.A.H.M.S GmbH
- Labeler DUNS
- 343844205
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f5644b1f-2fba-448a-95d1-ee3401e73b34
- Distribution End Date
- 2018-06-01
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSW | System,Test,Thyroglobulin | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54374 | Thyroglobulin IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroglobulin in a clinical specimen, using a radioimmunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260157631106 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021057 | 000 |