Identity
- Trade Name
- MedTest DX Homocysteine Controls FDA UDI
- Generic Name
- Homocysteine IVD, control FDA UDI
- Device Name
- The Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total Lhomocysteine in human serum or plasma. Size: 6 x 1.5ml FDA UDI
- Model / Reference
- HOMQ480 FDA UDI
- Description
- The Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total Lhomocysteine in human serum or plasma. Size: 6 x 1.5ml FDA UDI
Identifiers
- Catalog Number
- HOMQ480 FDA UDI
- Primary DI / UDI-DI
- 00817439020925 FDA UDI
- FDA Product Code
- LPS FDA UDI
- GMDN Term
- Homocysteine IVD, control 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 Controls 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 3cbff80d-1a5b-40d8-918a-c70db58275d5 37 fields · synced Jun 8, 2026