Identity
- Trade Name
- Teco Diagnostics LDH-L Reagent Set FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenase activity in human serum. FDA UDI
- Model / Reference
- L535-60 FDA UDI
- Description
- Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenase activity in human serum. FDA UDI
Identifiers
- Catalog Number
- L535-60 FDA UDI
- Primary DI / UDI-DI
- 10673486002065 FDA UDI
- 510(k) Number
- K874848 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
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: Total lactate dehydrogenase (LDH) IVD, reagent
Teco Diagnostics LDH-L Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total lactate dehydrogenase (LDH) IVD, reagent.
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- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- LDH L-P — Randox Laboratories, Ltd. · Class II
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- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- LDH — Randox Laboratories, Ltd. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
Cleared under the same submission
K874848 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 II | Pending data |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA UDI 6ca2dbda-d8db-4354-bcec-acc5d1e50817 37 fields · synced Jun 8, 2026