Identity
- Trade Name
- MedTest DX Homocysteine FDA UDI
- Generic Name
- Homocysteine IVD, kit, spectrophotometry FDA UDI
- Device Name
- Homocysteine, The Liquid Stable 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma on the Mindray BS-480 analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Size: 2 x 60ml, 2 x 12ml FDA UDI
- Model / Reference
- HOM480 FDA UDI
- Description
- Homocysteine, The Liquid Stable 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma on the Mindray BS-480 analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Size: 2 x 60ml, 2 x 12ml FDA UDI
Identifiers
- Catalog Number
- HOM480 FDA UDI
- Primary DI / UDI-DI
- 00817439020918 FDA UDI
- FDA Product Code
- LPS FDA UDI
- GMDN Term
- Homocysteine IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1377 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 Homocysteine 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 05eec3e0-1605-49e8-8b8f-507e78a17f35 37 fields · synced May 30, 2026