FDA UDI
In Commercial Distribution
🇺🇸 United States
Teco Diagnostics Direct LDL Cholesterol Reagent Set
DI: 10673486002010
·
Model: L530-100
·
TECO DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Teco Diagnostics Direct LDL Cholesterol Reagent Set
- Primary DI
- 10673486002010
- Version / Model
- L530-100
- Catalog Number
- L530-100
- 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
- 54e6fde9-0cf8-4afd-891c-09f5f259cb5e
Device Description
Teco Diagnostics Direct LDL Cholesterol Reagent Set is used for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.
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 |
|---|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53398 | Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10673486002010 | GS1 |
Customer Contacts
- Phone
- 7144631111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051121 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius