Identity
- Trade Name
- LDH FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, reagent FDA UDI
- Device Name
- The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma. FDA UDI
- Model / Reference
- LD2812 FDA UDI
- Description
- The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- LD2812 FDA UDI
- Primary DI / UDI-DI
- 05055273204100 FDA UDI
- 510(k) Number
- K970684 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
Yes
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
Ldh by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K970684 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI d8327e6e-f462-44bc-b2c4-de0c680655fd 37 fields · synced Jun 6, 2026