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Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix is for the quantitative determination of lactate dehydrogenase activity in serum or plasma on TC Matrix analyzers. FDA UDI
- Model / Reference
- L533-780TC2 FDA UDI
- Description
- Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix is for the quantitative determination of lactate dehydrogenase activity in serum or plasma on TC Matrix analyzers. FDA UDI
Identifiers
- Catalog Number
- L533-780TC2 FDA UDI
- Primary DI / UDI-DI
- 10673486002027 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total lactate dehydrogenase (LDH) IVD, reagent
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI f8dca7b1-549d-468d-ad95-48a96ec328d8 36 fields · synced May 30, 2026