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MedTest Dx, Inc. Lactate Dehydrogenase
FDA UDIClass II (US FDA UDI)
by Medtest DX
Identity
- Trade Name
- MedTest Dx, Inc. Lactate Dehydrogenase FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml FDA UDI
- Model / Reference
- LDH600 FDA UDI
- Description
- Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml FDA UDI
Identifiers
- Catalog Number
- LDH600 FDA UDI
- Primary DI / UDI-DI
- 00817439021007 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 FDA UDI
- Commercial Distribution
- Not 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
MedTest Dx, Inc. Lactate Dehydrogenase by Medtest DX — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtest DX
Sources (1)
- FDA UDI e0edc240-e17b-430e-a4a5-fdb53c5d7eaa 37 fields · synced May 30, 2026