FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc.
DI: 00811727013149
·
Model: T1007-96
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc.
- Primary DI
- 00811727013149
- Version / Model
- T1007-96
- Catalog Number
- T1007-96
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 5d8ec60a-8ea1-43af-8ed9-06604e93625c
Device Description
T4 for the quantitative determination of the Total Thyroxine (T4) concentration in human serum. For in vitro diagnostic use only. 96 Test
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | Clinical Chemistry | 862.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54395 | Multiple thyroid hormone uptake (T-uptake) IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, using a radioimmunoassay method. It is typically used to aid in the assessment of thyroid hormone binding capacity for the diagnosis of thyroid disorders associated with hypothyroidism or hyperthyroidism. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727013149 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991432 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius