FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Iron/TIBC Reagent Set
DI: 10673486001983
·
Model: I592-100
·
TECO DIAGNOSTICS
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Teco Diagnostics Iron/TIBC Reagent Set
- Primary DI
- 10673486001983
- Version / Model
- I592-100
- Catalog Number
- I592-100
- Company Name
- TECO DIAGNOSTICS
- Labeler DUNS
- 185067774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-13
- Public Version
- 1
- Public Version Date
- 2023-11-21
- Public Version Status
- New
- Public Device Record Key
- aa9da6c5-2fe2-4b40-9344-8b882d8f99fc
Device Description
Teco Diagnostics Iron/TIBC Reagent Set is used for the quantitative determination of iron, total iron-binding capacity in human serum.
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 |
|---|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | Clinical Chemistry | 862.1415 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | Clinical Chemistry | 862.1410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54762 | Iron IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of iron in a clinical specimen. | No | Active |
| 53908 | Total iron binding capacity IVD (TIBC), reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486001983 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K901561 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius