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Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix is used for quantitative determination of High Density Lipoprotein (HDL) Cholesterol in serum on TC Matrix analyzers. FDA UDI
- Model / Reference
- H513-330TM FDA UDI
- Description
- Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix is used for quantitative determination of High Density Lipoprotein (HDL) Cholesterol in serum on TC Matrix analyzers. FDA UDI
Identifiers
- Catalog Number
- H513-330TM FDA UDI
- Primary DI / UDI-DI
- 10673486001907 FDA UDI
- 510(k) Number
- K050823 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: High density lipoprotein (HDL) cholesterol IVD, reagent
Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as High density lipoprotein (HDL) cholesterol IVD, reagent.
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Cleared under the same submission
K050823 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 6a1883aa-b5d3-4b44-824b-1c0e7cd157bf 37 fields · synced May 30, 2026