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Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) FDA UDI
- Generic Name
- Lactate dehydrogenase 4 (LDH-4) isoenzyme IVD, reagent FDA UDI
- Model / Reference
- None FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970291985185 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Lactate dehydrogenase 4 (LDH-4) isoenzyme 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lactate dehydrogenase 4 (LDH-4) isoenzyme IVD, reagent
Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) by Medicalsystem Biotechnology Co., Ltd. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medicalsystem Biotechnology Co., Ltd.
Sources (2)
- FDA UDI fa0d9a43-77ed-4221-acea-6294f2f9299c 32 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 2, 2026